FDA Registration Active 🇩🇪 Germany

KAVO DENTAL GMBH

Reg #: 8010493 · FEI: 1344 · Expires 2026
Products
2
Proprietary Names
91
Establishment Types
2
Classifications
2

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Registration Details

Registration Name
KAVO DENTAL GMBH
Registration Number
8010493
FEI Number
1344
Status
Active
Expiry Year
2026
Initial Importer
No
Address
BISMARCKRING 39
City
BIBERACH Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K163317

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
Phone
704 2886058 ext. 0

Products

Device Name Product Code
Controller, Foot, Handpiece And Cord EBW
Handpiece, Air-Powered, Dental EFB

Proprietary Names

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 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 107.1700 - MASTERtorque Mini LUX M4500 L 108.7800 - MASTERtorque LUX M8900 L 301.3400 - MASTERtorque Mini LUX M8700 LK 301000 - MASTERtorque Mini LUX M8700 L 111.2330 - MASTERtorque Mini Kids-Edition en 301600 - MASTERtorque Mini LUX M8700 LS 301.2200 - MASTERtorque Mini LUX M8700 LY 107.7100 - MASTERtorque LUX M9000 L COLOR

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device