FDA Registration
Active
🇩🇪 Germany
KAVO DENTAL GMBH
Reg #: 3003637274
·
FEI: 3003637274
·
Expires 2026
Products
20
Proprietary Names
394
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- KAVO DENTAL GMBH
- Registration Number
- 3003637274
- FEI Number
- 3003637274
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BAHNHOFSTRASSE 20
- City
- WARTHAUSEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K060080
Owner / Operator
- Firm Name
- KaVo Dental GmbH
- Operator Number
- 10042139
- Address
- Bismarckring 39
- City
- Biberach
- State
- Baden-Wurttemberg
- Postal Code
- 88400
- Country
- DE
US Agent
- Business Name
- KaVo Dental Technologies, LLC
- Contact Name
- Crystal Bialek
- Address
- 11727 Fruehauf Drive
- City
- Charlotte
- State
- NC
- ZIP
- 28273
- Country
- US
- [email protected]
- Phone
- 704 2886058
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Caries Detector, Laser Light, Transmission | NTK | Class 2 | Dental | No | 2012-10-26 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2012-10-26 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2015-10-16 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2017-01-18 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2012-10-26 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2012-10-26 |
| Laser, Fluorescence Caries Detection | NBL | Class 2 | Dental | No | 2012-10-26 |
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | Class 1 | Dental | No | 2017-03-20 |
| Articulators | EJP | Class 1 | Dental | No | 2012-10-26 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2012-10-26 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2012-10-26 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2012-10-26 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-10-26 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2017-12-19 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2022-02-18 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2017-01-18 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2014-09-03 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2012-10-24 |
| Airbrush | KOJ | Class 2 | Dental | No | 2012-10-26 |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | Class 1 | Dental | No | 2012-10-26 |
Proprietary Names
102.7000 - DIAGNOdent pen 2190
102.8568 - DIAGNOdent Paro Tip Saphir with scale
104370 - DIAGNOdent Paro Tip Saphir without scale
104.8400 - DIAGNOdent Display 2191
108.2700 - KaVoLUX 540 LED
Dental Operating Lights
110.1826 - KaVo PROPHYpearls neutral
107014 - PROPHYflex powder orange
107015 - PROPHYflex powder berry
110.1830 - KaVo PROPHYpearls orange
102342 - PROPHYpearls
110.1798 - KaVo PROPHYpearls neutral
109.3732 - KaVo PROPHYflex Perio Powder
110.1829 - KaVo PROPHYpearls peach
110.1831 - KaVo PROPHYpearls black currant
107017 - PROPHYflex powder mint
107641 - PROPHYflex powder mailing
107016 - PROPHYflex powder cherry
110.1828 - KaVo PROPHYpearls mint
PIEZO Scaler Tip 203 - 107.4028
PIEZO Scaler Tip 201 - 107.4024
PIEZO Prep Tip 227 - 107.4036
PIEZO Prep Tip 226 - 107.4035
PIEZO Prep Tip 228 - 107.4037
PIEZO Implant Refill Tip Set - 107.4014
PIEZO Cem Tip 225 - 107.4027
PIEZO Implant Tip Set - 107.4008
PIEZO Prep Tip 229 - 107.4038
PIEZO Endo Tip 220 - 107.4040
PIEZO Paro Tip Set - 107.4006
PIEZO Scaler Tip Set - 107.4004
PIEZO Paro Tip 211 - 107.4042
PIEZO Scaler Tip 202 - 107.4026
PIEZO Paro Tip 214 - 107.4034
PIEZO Endo Tip 221 - 107.4041
PiezoLED - 107.3995
PIEZO Paro Tip 213 - 107.4033
PIEZO Paro Tip 212 - 107.4032
PIEZO Paro Tip 210 - 107.4039
PIEZO Endo Tip 222 - 107.4043
0.571402 - SONICflex clean Brush No. 1
104.3874 - SONICflex bone Set
100.4246 - SONICflex 2003
105.9328 - SONICflex scaler Tipset (A)
106.2022 - SONICflex rootplaner Tipset (A)
0.571.5651 - SONICflex rootplaner Tip No. 27
102.1988 - SONICflex prep CAD-CAM Tipset
0.571.7262 - SONICflex prep ceram Tip No. 51
106.1971 - SONICflex micro Tip No. 31 (A)
107.1607 - SONICflex 2008 S (Set)
100.7167 - SONICflex cari-ex 1.2 No. 43
100.5821 - SONICflex endo Tip No. 70
106.1936 - SONICflex paro Tip No.62 (A)
106.1973 - SONICflex micro Tip No. 32 (A)
106.2036 - SONICflex retro Tip No. 16 (A)
106.2006 - SONICflex bone Tip No. 80 (A)
100.8333 - SONICflex 2003 L (Set)
100.7105 - SONICflex cari-ex 0.8 No. 42
0.571.5601 - SONICflex retro, left
106.2010 - SONICflex bone Tip No. 82 (A)
106.2025 - SONICflex cari-ex D Tipset (A)
0.571.5431 - SONICflex cem Tip No. 12
106.2028 - SONICflex prep gold Tipset (A)
105.9310 - SONICflex 2008 L
106.1979 - SONICflex prep CAD/CAM No. 35 (A) distal
106.2029 - SONICflex prep ceram Tipset (A)
0.571432 - SONICflex clean Brush No. 4
106.2038 - SONICflex retro Tip No. 21 (A)
106.2014 - SONICflex bone Tip No. 84 (A)
100.1980 - SONICflex cari-ex 0.8 No. 42 (A)
0.571.5521 - SONICflex retro Tip No. 20
106.1934 - SONICflex paro Tip No.60 (A)
106.1935 - SONICflex paro Tip No.61 (A)
106.2034 - SONICflex retro Tipset (A)
106.2021 - SONICflex cemTip No. 12 (A)
106.2012 - SONICflex bone Tip No. 83 (A)
107541 - SONICflex 2008 S
106.1953 - SONICflex scaler Tip No. 8 (A)
100.1992 - SONICflex endo Tip No. 66 (A)
0.571.5611 - SONICflex retro, right
106.1986 - SONICflex prep ceram Tip No. 52 A
106.1965 - SONICflex micro Tip No. 28 (A)
105.9311 - SONICflex 2008
106.1982 - SONICflex clean Tip No.48 (A)
102.1986 - CAD-CAM distal gebogen No.35
100.5825 - SONICflex endo Tip No. 66
100.4983 - SONICflex scaler Tipset
100.5828 - SONICflex endo Tipset
106.2035 - SONICflex retro Tip No. 17 (A)
106.1990 - SONICflex bevel Tip No. 59 (A)
108.6386 - SONICflex prep crown plain Nr.98 A
106.1963 - SONICflex rootplaner Tip No. 27 (A)
0.571.7212 - SONICflex prep gold Tip No. 49
0.571.6741 - SONICflex micro Tip No. 28
0.571.5191 - SONICflex scaler Tip No. 7
0.571.5181 - SONICflex scaler Tip No. 6
105.8949 - SONICflex scaler Tip No. 5 (A)
106.2024 - SONICflex bone Tip No. 85 (A)
104.3878 - SONICflex bone Tip No. 83
0.571.6731 - SONICflex micro Tip No. 29
0.571421 - SONICflex micro Tipset
0.571371 - SONICflex paro Tipset
0.571.7402 - SONICflex paro Tip No.60
106.1969 - SONICflex micro Tip No. 30 (A)
0.571.7392 - SONICflex bevel Tip No. 58
106.2030 - SONICflex bevel Tipset (A)
106.2023 - SONICflex micro Tipset (A)
100.7379 - SONICflex cari-ex TC Tipset
106.1988 - SONICflex bevel Tip No. 58 (A)
0.571.5621 - SONICflex rootplaner Tip No. 24
0.571.7322 - SONICflex retro Tip No. 56
106.1967 - SONICflex micro Tip No. 29 (A)
103.8167 - SONICflex implant Set
106.1959 - SONICflex rootplaner Tip No. 25 (A)
106.2026 - SONICflex clean Brushset (A)
106.2002 - SONICflex cari-ex 1 No. 71 (A)
0.571.6811 - SONICflex micro Tip No. 30
0.571.6801 - SONICflex micro Tip No. 31
0.571321 - SONICflex prep gold Tipset
108.6384 - SONICflex prep crown round Nr.97 A
100.4243 - SONICflex 2003 L
105.8951 - SONICflex scaler Tip No. 7 (A)
106.2040 - SONICflex retro Tip No. 56 (A)
107.1604 - SONICflex 2008 L (Set)
100.7362 - SONICflex cari-ex 1 No. 71
100.5823 - SONICflex endo Tip No. 68
106.2037 - SONICflex retro Tip No. 20 (A)
100.1981 - SONICflex cari-ex 1.2 No. 43 (A)
102.1984 - CAD-CAM mesial gebogen No.34
0.571391 - SONICflex bevel Tipset
106.2008 - SONICflex bone Tip No. 81 (A)
100.7378 - SONICflex cari-ex D Tipset
105.8950 - SONICflex scaler Tip No. 6 (A)
106.2024 - SONICflex prep CAD-CAM Tipset (A)
0.571301 - SONICflex rootplaner Tipset
106.2004 - SONICflex cari-ex 1.4 No. 72 (A)
100.5827 - SONICflex endo Tip No. 69
100.1996 - SONICflex endo Tip No. 68 (A)
104.3877 - SONICflex bone Tip No. 82
106.2026 - SONICflex bone Tip No. 87 (A)
106645 - SONICflex bone Tip No. 85
106.1984 - SONICflex prep gold Tip No. 50 (A)
104.3876 - SONICflex bone Tip No. 81
100.7363 - SONICflex cari-ex 1.4 No. 72
107.1503 - SONICflex seal Tip No.45 (A)
0.571.7222 - SONICflex prep gold Tip No. 50
107540 - SONICflex 2008 LS
0.571401 - SONICflex clean Tip No. 48
0.571.6821 - SONICflex micro Tip No. 33
0.571422 - SONICflex clean Brush No. 3
0.571001 - SONICflex clean Brushset
0.571.5561 - SONICflex retro Tip No. 21
0.571.5171 - SONICflex scaler Tip No. 5
0.571472 - SONICflex clean Brush No. 5
0.571.5371 - SONICflex scaler Tip No. 8
100.2000 - SONICflex endo Tip No. 70 (A)
106.1961 - SONICflex rootplaner Tip No. 26 (A)
106741 - SONICflex bone Tip No. 86
0.571.7412 - SONICflex paro Tip No.61
100.2568 - SONICflex seal Tip No. 45
106.2031 - SONICflex endo Tipset (A)
0.571.5641 - SONICflex rootplaner Tip No. 26
107.1605 - SONICflex 2008 LS (Set)
100.5822 - SONICflex endo Tip No. 67
106.2032 - SONICflex cari-ex TC Tipset (A)
106.2020 - SONICflex paro Tipset (A)
0.571412 - SONICflex clean Brush No. 2
0.571.7342 - SONICflex retro Tip No. 55
106.1985 - SONICflex prep ceram Tip No. 51 (A)
0.571.5631 - SONICflex rootplaner Tip No. 25
104.3875 - SONICflex bone Tip No. 80
0.571.6831 - SONICflex micro Tip No. 32
0.571.5581 - SONICflex retro Tip No. 17
100.8334 - SONICflex 2003 (Set)
106.2025 - SONICflex bone Tip No. 86 (A)
104.3879 - SONICflex bone Tip No. 84
103.8168 - SONICflex implant refill
100.1994 - SONICflex endo Tip No. 67 (A)
106.1406 - SONICflex bone Tip No. 87
106.2041 - SONICflex retro Tip No. 57 (A)
106.2033 - SONICflex bone Set (A)
106.1957 - SONICflex rootplaner Tip No. 24 (A)
107.1606 - SONICflex 2008 (Set)
0.571.7382 - SONICflex bevel Tip No. 59
0.571331 - SONICflex prep ceram Tipset
0.571.5541 - SONICflex retro Tip No. 16
0.571.7332 - SONICflex retro Tip No. 57
0.571.7422 - SONICflex paro Tip No.62
0.571381 - SONICflex retro Tipset
100.1998 - SONICflex endo Tip No. 69 (A)
0.571482 - SONICflex clean Brush No. 6
106.1977 - SONICflex prep CAD/CAM No. 34 (A) mesial
106.2039 - SONICflex retro Tip No. 55 (A)
0.571.7272 - SONICflex prep ceram Tip No. 52
106.1975 - SONICflex micro Tip No. 33 (A)
106.2027 - SONICflex implant Set A
106.1983 - SONICflex prep gold Tip No. 49 (A)
108.6383 - SONICflex prep crown round tip no. 97
108.6385 - SONICflex prep crown plain tip no. 98
0.773000 - Multifunction LUX Syringe
0.773510 - 3-Function Syringe
109.2724 - 3-Function Syringe
0.773010 - Multifunction LUX Syringe
0.773500 - 3-Function Syringe
109.7840 - 3-Function Syringe
300.4808 - SURGtorque LUX S459 L
300.5063 - SURGtorque S459 C
108.1644 - SMARTtorque S609 C
108.1645 - SMARTtorque Mini S605 C
108.1641 - SMARTtorque LUX S619 L
108.1642 - SMARTtorque S619 C
108.1643 - SMARTtorque Mini LUX S615 L
110.1010 - DEXIS CariVu
104.1640 - DIAGNOdent 2095 perio tip
SMARTmatic PROPHY S19 - 111.6740
SMARTmatic PROPHY S31 K - 111.6761
SMARTmatic S20 S - 111.6752
SMARTmatic S10 K - 111.6731
SMARTmatic S10 S - 111.6732
SMARTmatic S10 - 111.6730
SMARTmatic ENDO S81 - 111.6780
SMARTmatic ENDO S321 - 111.6790
SMARTmatic S80 K - 111.6771
elements 8:1 - 111.6786
SMARTmatic PROPHY S31 - 111.6760
SMARTmatic S20 - 111.6750
SMARTmatic S53 - 111.6810
SMARTmatic S20 K - 111.6751
SMARTmatic PROPHY S19 K - 111.6741
SMARTmatic PROPHY S33 - 111.6800
0.535.5250 - INTRAmatic 181 M
0.535.5260 - INTRA 181 K 20 000 R.P.M.
0.535.5210 - INTRA L-LUX 181 L
0.535.5200 - INTRA-L-MOTOR 181 H
107.1700 - GENTLEmini LUX 4500BR
101.8776 - INTRA LUX Motor KL 701
107.3600 - EXPERTtorque Mini LUX E677 L
107.3580 - GENTLEpower LUX 25 LPR
0.535.6200 - INTRAflex LUX2 2329 LN
103.9882 - Trio-Pack 181P/181P/181P
107.5530 - EXPERTmatic E15 L
104.4503 - INTRAmatic 19 ES
101.7522 - POWERtorque 646 B
107.2400 - GENTLEsilence LUX 6500 BR
0.535.6220 - INTRAflex LUX2 2313 LN
106800 - EXPERTtorque E675 LMW
107.5540 - EXPERTmatic E20 L
103.1107 - INTRAmatic 20 E
0.553820 - COMPACTtorque 636 CP
103.6976 - INTRAmatic 31 E
108.1825 - INTRA Mini Kopf L52
108.1828 - INTRA EVA Kopf L61 G
108.1832 - INTRA Kopf L67
101.7454 - GENTLEpower LUX 29 LP
104.4456 - INTRA Kopf L80
103.6977 - INTRAmatic 10 E
108.1822 - INTRA Endo Kopf L3
107.5531 - EXPERTmatic E15 C
0.535.6190 - INTRAflex LUX2 2307 LN
103.2278 - PROPHYwiz 181 P
0.535.6210 - INTRAflex LUX2 2325 LN
101.7452 - GENTLEpower LUX 7 LP
106780 - GENTLEsilence LUX gold 8000 BR
106.6400 - EXPERTtorque E675 L
104.6403 - INTRAmatic 19 E
104.6401 - INTRAmatic 80 E
103.1109 - INTRAmatic 31 ES
107.5560 - EXPERTmatic E10 C
107.5550 - EXPERTmatic E25 L
0.535.6180 - INTRAflex LUX2 2320 LN
104.5380 - INTRAmatic 23 ES
101.5660 - GENTLEpower LUX 10 LP
103.1108 - INTRAmatic 14 E
108.4999 - EXPERTmatic E61 C
106.9200 - EXPERTtorque E679 L
108.1823 - INTRA Endo Kopf L3 Y
107.5551 - EXPERTmatic E25 C
107.5541 - EXPERTmatic E20 C
101.7453 - GENTLEpower LUX 20 LP
108.1829 - INTRA EVA Kopf L61 R
108.4998 - EXPERTmatic E31 C
108.1830 - INTRA Kopf L62
108.1835 - INTRA Micro Kopf L22
108.1824 - INTRA Prophy Kopf L31
108.1826 - INTRA Endo Kopf L53
108.1834 - INTRA Kopf L68 B
108.1831 - INTRA Kopf L66 B
108.1833 - INTRA Kopf L68
105900 - ARCUSevo
0.622.5000 - ARCUS
105.5000 - COMFORTdrive System
105169 - COMFORTtronic 4894
107.3570 - COMFORTdrive 200XDR
103.5622 - INTRAmatic LUX 702 KL
102.5015 - ELECTROtorque plus (Set)
101.8748 - ELECTROtorque plus
107150 - INTRAmatic KL 703 LED
103.3490 - ELECTROtorque TLC 4893
103.5840 - ELECTROtorque TLC 4893 (Set)
115960 - INTRA LUX KL703 LED Planmeca
0.574500 - DIAGNOdent 2095
0.411.9650 - KaVo Spray AMERICA 2113
105.3844 - QUATTROcare plus Spray AMERICA 2141
105.4524 - QUATTROcare plus Spray AMERICA 2141 (Set)
108525 - SonicFill Handpiece Lubrication Spray
0.411.9660 - KaVo Spray AMERICA 2113 (Set)
108.3805 - QUATTROcare PLUS 2124 A
302.8200 - PROPHYflex 4 Lime
113.4400 - PROPHYpearls Selection
304.5900 - PROPHYflex 4 S Wave
111.9403 - PROPHYflex 4 Perio Kit
304.5950 - PROPHYflex 4 S Flamingo
200922 - PROPHYflex perio tip
111.9400 - Adapter perio tip
304.5930 - PROPHYflex 4 S Lime
302.8000 - PROPHYflex 4 Wave
302.8800 - PROPHYflex 4 Flamingo
112.1000 - Power cannula
303.1138 - Cannula
110287 - Refill PROPHYflex perio tip
109.8757 - Tube Set S600
111.4444 - DEXIS CariVu 3-in-1 by KaVo
113.1700 - DEXIS CariVu 3-in-1 by KaVo U
111.1213 - DIAGNOcam Vision Full HD
113.1500 - DIAGNOcam Vision Full HD
115.3700 - DIAGNOcam Vision Full HD
109.1100 - SURGmatic S201 C
110.2332 - SURGmatic S201 XL
110.2333 - SURGmatic S201 XC
108.8000 - INTRA LUX S600 LED
109.1005 - SURGmatic S11 C
109470 - SURGmatic S201 L
109.1200 - MASTERsurg LUX
108.3500 - EXPERTsurg LUX
109.1010 - SURGmatic S11 L
111.4900 - SM5
110.8042 - Demo Unit EXPERTsurg LUX
110.9726 - Demo Unit MASTERsurg LUX
113.8662 - SURGmatic Head S201 XL Pro
113.7540 - SURGmatic S201 L Pro
113.8648 - SURGmatic Head S201 L Pro
113.7541 - SURGmatic S201 XL Pro
114.4000 - SURGmatic S15 L Pro
109.3580 - MASTERmatic M29 L
109.3620 - MASTERmatic M20 L
109.3610 - MASTERmatic M07 L
109.3640 - MASTERmatic M05 L
109.3570 - MASTERmatic M10 L
109.3630 - MASTERmatic M25 L
114280 - MASTERmatic LUX M45 L
107.2000 - SonicFill Handpiece 34920
Satelec Mini LED - 103.8119
KaVo multiCAD Zahnbibliothek - 110.1728
KaVo multiCAD - 108.9312
KaVo multiCAD Eierschalenprovisorium - 109814
KaVo multiCAD virtueller Artikulator ARCUSdigma - 109812
KaVo multiCAD Aufbissschienen - 109813
0.579.1000 - CORONAflex 2005
100.5955 - RONDOflex powder 27µm (75g)
100.5957 - RONDOflex powder 27µm (1000g)
102.2179 - RONDOflex plus 360
100.5954 - RONDOflex powder 50µm (75g)
100.5956 - RONDOflex powder 50µm (1000g)
ELECTROmatic PM/PC - 111.1900
ELECTROmatic T2M - S - 113311
ELECTROmatic M - S - 112.8537
ELECTROmatic TM - 111.2100
ELECTROmatic C - S - 112.8539
ELECTROmatic PC - L - 112.8544
ELECTROmatic PC - S - 112.8543
ELECTROmatic M/C - 111.1800
ELECTROmatic M - L - 112.8538
ELECTROmatic TMC - S - 112.8549
ELECTROmatic TM - S - 112.8545
ELECTROmatic PM - L - 112.8542
ELECTROmatic TMM - L - 112.8548
ELECTROmatic PM - S - 112.8541
ELECTROmatic TMM - S - 112.8547
ELECTROmatic C - L - 112.8540
ELECTROmatic TM - L - 112.8546
ELECTROmatic TMC - L - 112.8550
ELECTROmatic TMM/TMC - 111.2600
elements e-motion - 113.3300
INTRA LUX Motor KL 703 LED - 107150
handpiece tubing 1.830 A-dec - 114.7770
COMFORTdrive 200 XD - 100.5500
Handpiece tubing 1.370 A-dec - 114.5690
Orion Dual Motor Control - 111.7169
109.3732 - KaVo PROPHYflex Perio Powder (4x Fl.)
110.1798 - KaVo PROPHYpearls neutral (4x 1 Fl.)
100.4672 - PROPHYflex 3 2018 black
106.9926 - PROPHYflex 3 2018 violet
106.9928 - PROPHYflex 3 2018 green
105.2301 - ARCUS digma USB
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)