FDA Registration
Active
🇺🇸 United States
MUCOTOME
Reg #: 3011276344
·
FEI: 3011276344
·
Expires 2025
Products
1
Proprietary Names
329
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SWEDEN & MARTINA INC
- Registration Number
- 3011276344
- FEI Number
- 3011276344
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 916 SPINDLETREE AVENUE
- City
- Naperville
- State
- IL
- ZIP
- 60565
- Country
- US
Owner / Operator
- Firm Name
- Sweden & Martina INC
- Operator Number
- 10048147
- Address
- 916 SPINDLETREE AVENUE
- City
- Naperville
- State
- IL
- Postal Code
- 60565
- Country
- US
- Correspondent
- Alessia Pezzato
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2018-12-03 |
Proprietary Names
MUCOTOME
PEEK OSTEOTOME TIP
EXTRACTOR SCREW
STOP H.4,5 MM FOR DRILL
HAND DRIVER FOR R.A. INSTRUM.
PARALLELISM PIN WITH DEPTH
HAND SCREWDRIVER FOR BALL
EXTENSION FOR SURGICAL DRILLS
STOP H.6 MM FOR DRILL
HAND KNOB FOR DRIVERS, BONE
TRANSFER ECHO FOR PREMIUM
LONG DRILL DIAM. 4,00 MM
SURGICAL HAND SCREWDRIVER FOR
SHORT DIGITAL RETENT. DRIVER
TORQUE CONTROLLED RATCHET KIT
SHORT STOP H. 11,5, D. 4,15 MM
SHORT STOP H. 8,5, D. 4,15 MM
INTERMEDIATE DRILL D. 2.50 MM
CYLINDRICAL FINAL DRILL
HEXAGONAL SCREWDRIVER FOR
PLUGGER AND DEPTH GAUGE
HOLDER FOR PREMIUM SP
SHORT STOP H. 10, D. 5,50 MM
BONE TAP PRE/OUT D. 3,30 MM
EXTRA LONG PROSTHETIC HAND
TRY-IN KIT FOR PREMIUM/KOHNO
PROSTHETIC ACCESSORIES KIT
SURGICAL SLEEVE WITH HEX.DIAM.
NON RETENTIVE DIGITAL DRIVER
BOX FOR PRE-MADE ABUTMENT
BONE TAP PREMIUM SP D.3,80 MM
FINAL CONICAL DRILL SHELTA
O-RING KIT FOR INSTRUMENTS
TI POST ANATOMICAL
SHORT DRILL DIAM. 3,30 MM
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 13 MM
BONE EXPANDER FOR D.B.E
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 8.5 MM
TRANSFER 3.80 PR/SH
STOP UNLOCKING HANDLE
PRE-MADE REP. ABUT STRAIGHT
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 11.5 MM
SHORTY DRILLING KIT
"SURGICAL KIT ""ONEBOX"""
COUNTERSINK DRILL
SHORT DRILL DIAM. 3,60 MM
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 10 MM
LONG DRILL DIAM. 2,00 MM
RETENT.EASY INSERT HAND DRIVER
SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM
LONG STOP H. 15, D. 4,15 MM
HOLDER FOR PREMIUM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 8.5 MM
SHORT HAND BONE TAP
HAND BONE TAP FOR GLOBAL
TORQUE WRENCH WITH LEVER
SHORT STOP H. 11,5, D. 5,50 MM
REPLY FOR GLOBAL IMPLANT
BONE TAP FOR OUTLINK2
HAND DRIVER FOR TITANIUM CAP
MOUNTER STOP KEY
TRANSFER 3.30 PR/SH
SHORT DRILL DIAM. 3,00 MM
INSTRUMENTS TRAY FOR
CLOSED TRAY TRANSFER
SURG. KIT FOR PREMIUM-SHELTA
LONG DRILL DIAM. 2,80 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 13 MM
MOUNTER TRAY ORGANIZER
SCANBODY iNTRAORAL
COUNTER ANGLE FOR SURGERY 20:1
ROUNDED DRILL D. 40 MM
CYLINDRICAL PILOT DRILL
STOP UNLOCKING HOLDER
STOP H.13 MM FOR DRILL
SUPPLEMENTARY KIT PREMIUM
PILOT DRILL GLOBAL
NON RETENT. SHORT HAND DRIVER
CASTABLE CAP FOR PREMADE ABUT
"SURGICAL KIT ""ONEBOX2"""
TRANSFER 4.25 PR/SH
MOUNTER OUTLINK2 D. 5,00 MM
REPLY FOR SHELTA IMPLANT
LONG DRILL DIAM. 3,20 MM
SURGICAL SLEEVE DIAM. 5,50 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 13 MM
GLOBAL BONE EXPANDER KIT
SURGICAL KIT ECHOPLAN
RIGHT ANGLE CONNECTOR
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 10 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 11.5 MM
REPLIES FOR SHELTA IMPLANTS
SURGICAL KIT FOR PRAMA
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 10 MM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 8.5 MM
LONG DRIVER FOR GLOBAL IMPL.
SURGICAL KIT ONEBOX FOR PREMIUM IMPLANT SYSTEM
CHAMFERED DRILL D. 30 MM
MOUNTER WITH SCREW FOR PRE/KOH
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 15 MM
LONG STOP H. 13, D. 5,50 MM
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 11.5 MM
RIGHT ANGLE SCREWDRIVER
BREAK UP DRILL D. 30 MM
SHORT DRILL DIAM. 2,50 MM
HAND BONE TAP FOR PRE/KOH
STOP H.7 MM FOR DRILL
UNIVERSAL INITIAL MUCOTOME
XS SURGICAL HAND SCREWDRIVER
SHORT DRILL DIAM. 2,80 MM
SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM
TRANSFER ECHO FOR PRE-KOH TG
MOUNTER PRAMA, FOR SLEEVE
BONE TAP PREMIUM D. 4,25 MM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 11.5 MM
SHORT STOP H. 7, D. 5,50 MM
DOUBLE MOUNTER STOP KEY FOR
HAND DRIVER FOR ABUTMENT
LONG SURGIC. HAND SCREWDRIVER
SURGICAL SLEEVE DIAM. 4,15 MM
TAPERED FINAL DRILL
DOUBLE TIP PLUGGER
GLOBAL BONE PROFILER
ROUND TIP OSTEOTOME D.90
ROUND TIP OSTEOTOME D.20
STOP H.1 MM FOR DRILL
REMOVAL SCREW KIT FOR PRE/KOH
CSR STOP FOR CYLINDRICAL DRILL
MOUNTER HAND DRIVER
ANALOGUE FOR PRAMA IMPLANT
CRCO POST STRAIGHT
CASTABLE POST,NON REP., CR-CO
TI POST STRAIGHT
CASTABLE POST,NON REP., GOLD
CASTABLE POST, REP., CR-CO
BONE PROFILER SLEEVE
SHORT PROSTHETIC HAND
ANALOGUE FOR ABUTMENT
SHORT DRILL DIAM. 4,25 MM
PILOT DRILL
HAND BONE TAP FOR KOHNO
ABUTMENT ECHO OUTLINK2
SHORT SURGIC. HAND SCREWDRIVER
SILICONE SUPPORT FOR SURGICAL
TITANIUM SUPPORT
TRANSFER ECHO FOR GLOBAL
M.I.S.E. EVO KIT
TEMP. CAP FOR PRE-MADE ABUT
SUPPLEMENTARY INSTRUM. SET
SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM
RETENT.LONG R.A. EASY INSERT
ABUTMENT ECHO GLOBAL
FLAT TIP OSTEOTOME FOR SHELTA
CONCAVE TIP OSTEOTOME D.2.40
LONG STOP H. 15, D. 5,50 MM
MILLABLE TITANIUM SLEEVE
LONG STOP H. 13, D. 4,15 MM
EXTRA SHORT SURGICAL HAND
COUNTERSINK FOR PREMIUM SP
ROUNDED DRILL D. 3.40 MM
TRANSFER ECHO FOR OUTLINK2
PINS DRILL
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 8.5 MM
SCREW KIT
LONG DRILL DIAM. 4,25 MM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 13 MM
TRANSFER P.A.D. FOR CAD-CAM
STOP H.8 MM FOR DRILL
LONG DRILL DIAM. 3,30 MM
LONG DRILL DIAM. 2,90 MM
SUPPLEMENTARY DRILLS SET
STOP H.9 MM FOR DRILL
LONG DRILL DIAM. 3,60 MM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 11.5 MM
SURGICAL KIT FOR SHELTA IMPLANT SYSTEM
LONG PROSTHETIC HAND
STOP H.2 MM FOR DRILL
RIGHT ANGLE DRIVER FOR GLOBAL-
TEFLON CAP CONTAINER FOR BALL
RIGHT ANGLE RETENTIVE DRIVER
SURGICAL KIT "ONEBOX2"
LONG DIGITAL RETENTIVE DRIVER
SURGICAL KIT ECHOPLAN PRO
HAND BONE TAP FOR PREMIUM
SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM
INITIAL DRILL BUILT-IN STOP
LONG DRILL DIAM. 3,00 MM
EXTENSION FOR HAND SCREWDRIVER
STOP H.3 MM FOR DRILL
FINAL CYLINDRICAL DRILL
TAPERED FINAL DRILL UNDERP.
FINAL CONICAL DRILL GLOBAL
PERI-SET , KIT FOR SURGICAL
STOP FOR SHORT DRILL
HANDLE FOR D.B.E.SYSTEM
LONG SCREW DRIVER FOR LOCATOR
TRANSFER P.A.D.
MILLABLE CRCO ABUTMENT
ABUTMENT ECHO KOHNO
SURGICAL SLEEVE FOR ANCHOR PIN
BONE TAP PREMIUM D. 3,80 MM
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 15 MM
STOP H.12 MM FOR DRILL
SURGICAL KIT
TEMPORARY ABUTMENT
SCREW ZIRCONIUM ABUTMENT
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 15 MM
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 11.5 MM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 15 MM
SHORT STOP H. 8,5, D. 5,50 MM
ROUND TIP OSTEOTOME FOR SHELTA
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 10 MM
PREMIUM BONE PROFILER
CONCAVE TIP OSTEOTOME D.20
SHORT DRILL DIAM. 3,40 MM
ANCHOR PIN
MOUNTER OUTLINK2 D. 4,10 MM
RIGHT ANGLE SCREWDRIVER FOR
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 15 MM
PEEK CAP FOR PREMADE POST
SUPPLEMENTARY KIT OUTLINK2
SHORT SCREW DRIVER FOR LOCATOR
DEPTH GAUGE HOLE IMPLANTS
PARALLEL PIN
SHORT DRILL DIAM. 4,00 MM
CARRIER FOR ANGLED ABUTMENT
PRE/KOH BONE PROFILER
CONICAL DRILL
ABUTMENT ECHO PREMIUM
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 8.5 MM
BONE TAP PREMIUM D. 5,00 MM
LONG DRILL DIAM. 3,80 MM
SHORT DRILL DIAM. 2,00 MM
HAND BONE TAP FOR SHELTA
KIT D.B.E. SYSTEM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 13 MM
HEALING CAP FOR PRE-MADE ABUT
SHORT STOP H. 7, D. 4,15 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 10 MM
PREMIUM SURGICAL KIT ECHOPLAN
TAPERED BONE TAP
STOP H.10 MM FOR DRILL
ABUTMENT ECHO PREMIUM-KOHNO
SHORT DRILL DIAM. 3,20 MM
OUTLINK2 SUPPLEMENTARY INSTR.
TRY-IN KIT FOR PREMIUM
INITIAL DRILL D. 20 MM
X-RAY TEMPLATES
CONCAVE TIP OSTEOTOME D.1.60
COUNTERSINK DRILL D.4.10 MM
STOP FOR CONICAL DRILL
SURGICAL KIT ONEBOX2 FOR OUTLINK2 IMPLANT SYSTEM
COUNTERSINK FOR OUTLINK2
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 10 MM
SHORT STOP H. 10, D. 4,15 MM
STOP H.5 MM FOR DRILL
SILICONE SUPPORT FOR SCREWKIT
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 11.5 MM
STOP H.4 MM FOR DRILL
PREMIUM SUPPLEMENTARY INSTR.
MILLABLE TITANIUM ABUTMENT
INTERMEDIATE DRILL
TITANIUM SLEEVE
UNIVERSAL BONE PROFILER
OUTLINK2 SURGICAL KIT ECHOPLAN
RIGHT ANGLE BONE TAP
ROUND TIP OSTEOTOME FOR GLOBAL
INTRAORAL SCANBODY
STOP FOR CYLINDRICAL DRILL
INSTRUMENT TRAY ECHOPLAN
REMOVAL SCREW KIT FOR GLOBAL
LONG DRILL DIAM. 3,40 MM
ROUNDED DRILL D. 30 MM
REMOVAL SCREW KIT FOR OUTLINK2
MOUNTER OUTLINK2 D. 3,30 MM
EXTRALONG PROSTHETIC HAND
TEFLON CAP BALL ATTACHMENTS
PRE-MADE REP. ABUT ANATOMICAL
PRECISION DRILL
SHORT DRILL DIAM. 2,90 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 8.5 MM
SURGICAL KIT "ONEBOX"
BRUSH
RETENT.SHORT R.A. EASY INSERT
STOP FOR CONICAL SYRA SHORT
ABUTMENT SCREW M1.8
NECK POSITION PIN
ABUTMENT SCREW M 2
SHORT DRILL DIAM. 3,80 MM
NON RETENT. LONG HAND DRIVER
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 13 MM
TRANSFER 50 PR/SH
PULL-UP TRANSFER
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 10 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 8.5 MM
POST SCREW FOR PRAMA IMPLANT
CRCO POST ANATOMICAL
X-RAY TEMPLATES FOR PRAMA AND
PICK-UP TRANSFER FOR PRAMA
LONG DRILL DIAM. 2,50 MM
INTERMEDIATE DRILL GLOBAL
MOUNTER STOP KEY FOR
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 15 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 15 MM
STOP H.11 MM FOR DRILL
SPARE CAST. SLEEVE FOR GOLD
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 13 MM
FINAL CONICAL DRILL SYRA SHORT
ABUTMENT TIT. D.12
SPIRAL DRILL
EASY MOUNTER
M-TWO INSTRUMENT
GUIDED SURGERY PIVOT
CLUTCH DRILL
PIN
STOP H.2,5 MM FOR DRILL
SCREW
MOUNTER
INSERTION INSTRUMENT
DIGITAL ANALOGUE
STOP H.5,5 MM FOR DRILL
STOP H.3,5 MM FOR DRILL
STOP H.1,5 MM FOR DRILL
MOUNTER SCREW
DEPTH GAUGE
CURVED HANDLE
DRILL
MASTER SLEEVE
HANDLE
Establishment Types
Complaint File Establishment per 21 CFR 820.198