FDA Registration
Active
🇮🇹 Italy
STOP H.4,5 MM FOR DRILL
Reg #: 3001082453
·
FEI: 3001082453
·
Expires 2025
Products
1
Proprietary Names
333
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SWEDEN & MARTINA S.P.A.
- Registration Number
- 3001082453
- FEI Number
- 3001082453
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Via Veneto, 10
- City
- Due Carrare Padova
- Country
- IT
Owner / Operator
- Firm Name
- SWEDEN & MARTINA S.p.A.
- Operator Number
- 10046682
- Address
- Via Veneto, 10
- City
- Due Carrare
- State
- Padova
- Postal Code
- 35020
- Country
- IT
US Agent
- Business Name
- THEMA CORP
- Contact Name
- Silvia Tamarri
- Address
- 2929 Arch Street
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
- [email protected]
- Phone
- 215 8459459
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2014-07-18 |
Proprietary Names
STOP H.4,5 MM FOR DRILL
STOP H.5,5 MM FOR DRILL
DRILL
MUCOTOME
MOUNTER
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 10 MM
DOUBLE TIP PLUGGER
REPLY FOR GLOBAL IMPLANT
SHORTY DRILLING KIT
SURGICAL KIT ONEBOX2 FOR OUTLINK2 IMPLANT SYSTEM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 8.5 MM
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 11.5 MM
SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM
SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM
SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM
SUPPLEMENTARY KIT OUTLINK2
SCREW KIT
PLUGGER AND DEPTH GAUGE
OUTLINK2 SURGICAL KIT ECHOPLAN
TRANSFER ECHO FOR PREMIUM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 13 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 10 MM
BONE EXPANDER FOR D.B.E
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 8.5 MM
STOP H.5 MM FOR DRILL
REMOVAL SCREW KIT FOR PRE/KOH
STOP H.7 MM FOR DRILL
SUPPLEMENTARY KIT PREMIUM
ROUND TIP OSTEOTOME FOR GLOBAL
KIT D.B.E. SYSTEM
BREAK UP DRILL D. 30 MM
PREMIUM SUPPLEMENTARY INSTR.
ABUTMENT ECHO GLOBAL
NON RETENTIVE DIGITAL DRIVER
TRANSFER ECHO FOR GLOBAL
TRANSFER 50 PR/SH
ROUNDED DRILL D. 30 MM
TRANSFER P.A.D.
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 15 MM
STOP H.11 MM FOR DRILL
UNIVERSAL INITIAL MUCOTOME
REPLIES FOR SHELTA IMPLANTS
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 13 MM
HANDLE FOR D.B.E.SYSTEM
STOP H.1 MM FOR DRILL
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 8.5 MM
PREMIUM SURGICAL KIT ECHOPLAN
TRANSFER ECHO FOR OUTLINK2
ROUNDED DRILL D. 3.40 MM
STOP H.8 MM FOR DRILL
TRANSFER ECHO FOR PRE-KOH TG
REPLY FOR SHELTA IMPLANT
SUPPLEMENTARY DRILLS SET
TRANSFER 3.30 PR/SH
SURGICAL KIT FOR PRAMA
RIGHT ANGLE RETENTIVE DRIVER
SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM
COUNTER ANGLE FOR SURGERY 20:1
TRY-IN KIT FOR PREMIUM/KOHNO
SURGICAL KIT ONEBOX FOR PREMIUM IMPLANT SYSTEM
SURGICAL KIT
HOLDER FOR PREMIUM
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 11.5 MM
LONG DRILL DIAM. 2,90 MM
COUNTERSINK FOR OUTLINK2
SURGICAL HAND SCREWDRIVER FOR
BONE TAP PREMIUM D. 5,00 MM
MOUNTER OUTLINK2 D. 5,00 MM
SURGICAL KIT FOR SHELTA IMPLANT SYSTEM
ROUNDED DRILL D. 40 MM
STOP UNLOCKING HANDLE
LONG DRILL DIAM. 3,60 MM
DOUBLE MOUNTER STOP KEY FOR
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 15 MM
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 15 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 11.5 MM
MILLABLE CRCO ABUTMENT
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 13 MM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 10 MM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 10 MM
LONG DRILL DIAM. 3,30 MM
SHORT DRILL DIAM. 3,00 MM
LONG STOP H. 15, D. 4,15 MM
SHORT DRILL DIAM. 3,40 MM
OUTLINK2 SUPPLEMENTARY INSTR.
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 10 MM
STOP H.4 MM FOR DRILL
UNIVERSAL BONE PROFILER
HOLDER FOR PREMIUM SP
FINAL CONICAL DRILL GLOBAL
SHORT DRILL DIAM. 4,25 MM
SHORT DRILL DIAM. 2,50 MM
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 13 MM
HAND BONE TAP FOR SHELTA
REMOVAL SCREW KIT FOR OUTLINK2
HAND BONE TAP FOR PRE/KOH
SHORT HAND BONE TAP
FINAL CYLINDRICAL DRILL
LONG DRILL DIAM. 2,50 MM
LONG DRILL DIAM. 2,00 MM
SILICONE SUPPORT FOR SURGICAL
RETENT.EASY INSERT HAND DRIVER
TRANSFER 4.25 PR/SH
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 11.5 MM
STOP H.10 MM FOR DRILL
LONG DIGITAL RETENTIVE DRIVER
CHAMFERED DRILL D. 30 MM
STOP FOR CONICAL DRILL
INTERMEDIATE DRILL
CONCAVE TIP OSTEOTOME D.20
INSTRUMENT TRAY ECHOPLAN
INTERMEDIATE DRILL GLOBAL
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 15 MM
PARALLELISM PIN WITH DEPTH
SHORT DRILL DIAM. 2,90 MM
LONG DRILL DIAM. 3,80 MM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 13 MM
INITIAL DRILL D. 20 MM
STOP H.9 MM FOR DRILL
PROSTHETIC ACCESSORIES KIT
ABUTMENT ECHO OUTLINK2
SHORT DIGITAL RETENT. DRIVER
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 10 MM
ROUND TIP OSTEOTOME FOR SHELTA
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 8.5 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 15 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 11.5 MM
STOP H.2 MM FOR DRILL
LONG DRILL DIAM. 3,20 MM
SHORT STOP H. 10, D. 4,15 MM
"SURGICAL KIT ""ONEBOX2"""
SHORT PROSTHETIC HAND
ABUTMENT ECHO KOHNO
LONG SURGIC. HAND SCREWDRIVER
EXTRA SHORT SURGICAL HAND
HAND DRIVER FOR TITANIUM CAP
COUNTERSINK DRILL D.4.10 MM
SURGICAL KIT "ONEBOX2"
CYLINDRICAL PILOT DRILL
TRY-IN KIT FOR PREMIUM
REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 11.5 MM
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 13 MM
REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 8.5 MM
SURGICAL SLEEVE DIAM. 5,50 MM
LONG DRIVER FOR GLOBAL IMPL.
ABUTMENT ECHO PREMIUM
MOUNTER STOP KEY FOR
M.I.S.E. EVO KIT
REPLY FOR SHELTA IMPLANT D. 50 MM, L. 8.5 MM
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 13 MM
SHORT SURGIC. HAND SCREWDRIVER
HAND DRIVER FOR ABUTMENT
SURGICAL KIT ECHOPLAN
NON RETENT. SHORT HAND DRIVER
ABUTMENT ECHO PREMIUM-KOHNO
RIGHT ANGLE DRIVER FOR GLOBAL-
PARALLEL PIN
HAND BONE TAP FOR KOHNO
HAND KNOB FOR DRIVERS, BONE
INTERMEDIATE DRILL D. 2.50 MM
ROUND TIP OSTEOTOME D.20
HAND SCREWDRIVER FOR BALL
X-RAY TEMPLATES
TITANIUM SUPPORT
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 15 MM
SURGICAL KIT "ONEBOX"
PERI-SET , KIT FOR SURGICAL
REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 11.5 MM
SHORT DRILL DIAM. 3,60 MM
BONE TAP PREMIUM D. 4,25 MM
TEFLON CAP CONTAINER FOR BALL
"SURGICAL KIT ""ONEBOX"""
MOUNTER OUTLINK2 D. 4,10 MM
STOP H.3 MM FOR DRILL
REMOVAL SCREW KIT FOR GLOBAL
PILOT DRILL GLOBAL
MILLABLE TITANIUM ABUTMENT
SHORT DRILL DIAM. 3,30 MM
STOP UNLOCKING HOLDER
STOP H.6 MM FOR DRILL
GLOBAL BONE EXPANDER KIT
STOP H.12 MM FOR DRILL
STOP H.13 MM FOR DRILL
INITIAL DRILL BUILT-IN STOP
SHORT DRILL DIAM. 4,00 MM
TRANSFER 3.80 PR/SH
GLOBAL BONE PROFILER
MOUNTER HAND DRIVER
SHORT STOP H. 11,5, D. 4,15 MM
REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 15 MM
RIGHT ANGLE SCREWDRIVER FOR
SHORT STOP H. 11,5, D. 5,50 MM
O-RING KIT FOR INSTRUMENTS
COUNTERSINK FOR PREMIUM SP
SHORT STOP H. 10, D. 5,50 MM
HAND BONE TAP FOR GLOBAL
ROUND TIP OSTEOTOME D.90
LONG STOP H. 13, D. 5,50 MM
LONG DRILL DIAM. 4,00 MM
STOP FOR CYLINDRICAL DRILL
DEPTH GAUGE HOLE IMPLANTS
FLAT TIP OSTEOTOME FOR SHELTA
SILICONE SUPPORT FOR SCREWKIT
MOUNTER WITH SCREW FOR PRE/KOH
RETENT.LONG R.A. EASY INSERT
BONE TAP PRE/OUT D. 3,30 MM
SHORT STOP H. 8,5, D. 5,50 MM
SURGICAL SLEEVE DIAM. 4,15 MM
BONE TAP FOR OUTLINK2
SURG. KIT FOR PREMIUM-SHELTA
MOUNTER STOP KEY
NON RETENT. LONG HAND DRIVER
BONE TAP PREMIUM SP D.3,80 MM
SHORT STOP H. 7, D. 5,50 MM
PRECISION DRILL
PREMIUM BONE PROFILER
PRE-MADE REP. ABUT ANATOMICAL
TRANSFER P.A.D. FOR CAD-CAM
PRE/KOH BONE PROFILER
REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 10 MM
REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 8.5 MM
SHORT DRILL DIAM. 2,80 MM
LONG DRILL DIAM. 4,25 MM
BRUSH
FINAL CONICAL DRILL SHELTA
LONG SCREW DRIVER FOR LOCATOR
XS SURGICAL HAND SCREWDRIVER
SHORT STOP H. 8,5, D. 4,15 MM
LONG DRILL DIAM. 3,00 MM
TEFLON CAP BALL ATTACHMENTS
LONG DRILL DIAM. 3,40 MM
LONG STOP H. 15, D. 5,50 MM
EXTENSION FOR SURGICAL DRILLS
LONG PROSTHETIC HAND
HAND BONE TAP FOR PREMIUM
TORQUE CONTROLLED RATCHET KIT
RETENT.SHORT R.A. EASY INSERT
MOUNTER OUTLINK2 D. 3,30 MM
LONG DRILL DIAM. 2,80 MM
SHORT STOP H. 7, D. 4,15 MM
SHORT DRILL DIAM. 2,00 MM
CONICAL DRILL
SHORT DRILL DIAM. 3,80 MM
EXTENSION FOR HAND SCREWDRIVER
RIGHT ANGLE BONE TAP
SHORT SCREW DRIVER FOR LOCATOR
LONG STOP H. 13, D. 4,15 MM
STOP FOR SHORT DRILL
CONCAVE TIP OSTEOTOME D.1.60
HAND DRIVER FOR R.A. INSTRUM.
INSTRUMENTS TRAY FOR
SURGICAL SLEEVE WITH HEX.DIAM.
EXTRA LONG PROSTHETIC HAND
CONCAVE TIP OSTEOTOME D.2.40
CARRIER FOR ANGLED ABUTMENT
RIGHT ANGLE CONNECTOR
HEXAGONAL SCREWDRIVER FOR
SHORT DRILL DIAM. 3,20 MM
BONE TAP PREMIUM D. 3,80 MM
TORQUE WRENCH WITH LEVER
HEALING CAP FOR PRE-MADE ABUT
PILOT DRILL
CSR STOP FOR CYLINDRICAL DRILL
PRE-MADE REP. ABUT STRAIGHT
BOX FOR PRE-MADE ABUTMENT
CASTABLE CAP FOR PREMADE ABUT
SCANBODY iNTRAORAL
TEMPORARY ABUTMENT
PEEK CAP FOR PREMADE POST
TEMP. CAP FOR PRE-MADE ABUT
MILLABLE TITANIUM SLEEVE
ANALOGUE FOR ABUTMENT
RIGHT ANGLE SCREWDRIVER
SCREW ZIRCONIUM ABUTMENT
SPARE CAST. SLEEVE FOR GOLD
COUNTERSINK DRILL
INTRAORAL SCANBODY
SURGICAL KIT ECHOPLAN PRO
TAPERED FINAL DRILL
TI POST STRAIGHT
CLOSED TRAY TRANSFER
MOUNTER PRAMA, FOR SLEEVE
TITANIUM SLEEVE
SUPPLEMENTARY INSTRUM. SET
PINS DRILL
PULL-UP TRANSFER
EXTRALONG PROSTHETIC HAND
PICK-UP TRANSFER FOR PRAMA
BONE PROFILER SLEEVE
POST SCREW FOR PRAMA IMPLANT
CYLINDRICAL FINAL DRILL
ABUTMENT SCREW M 2
ANCHOR PIN
TAPERED FINAL DRILL UNDERP.
SURGICAL SLEEVE FOR ANCHOR PIN
MOUNTER TRAY ORGANIZER
CASTABLE POST,NON REP., GOLD
X-RAY TEMPLATES FOR PRAMA AND
CASTABLE POST, REP., CR-CO
ABUTMENT TIT. D.12
TAPERED BONE TAP
CRCO POST ANATOMICAL
ABUTMENT SCREW M1.8
FINAL CONICAL DRILL SYRA SHORT
TI POST ANATOMICAL
ANALOGUE FOR PRAMA IMPLANT
STOP FOR CONICAL SYRA SHORT
CRCO POST STRAIGHT
CASTABLE POST,NON REP., CR-CO
M-TWO INSTRUMENT
HANDLE FOR MANUAL INSERTION
NECK POSITION PIN
CLUTCH DRILL
SPIRAL DRILL
EASY MOUNTER
GUIDED SURGERY PIVOT
PARALLELOMETER
PIN
THREAD FORMER M.1.8
SCREW
DIGITAL ANALOGUE
MOUNTER SCREW
INSERTION INSTRUMENT
HANDLE
STOP H.2,5 MM FOR DRILL
CURVED HANDLE
THREAD FORMER M.2
PEEK OSTEOTOME TIP
MASTER SLEEVE
EXTRACTOR SCREW
STOP H.3,5 MM FOR DRILL
STOP H.1,5 MM FOR DRILL
DEPTH GAUGE
Establishment Types
Manufacture Medical Device