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
Accessories, Implant, Dental, Endosseous NDP

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