Identity
- Trade Name
- Composite Instrument EUDAMEDComposi-Tight® FDA UDI
- Generic Name
- Dental restoration carver, resin FDA UDI
- Device Name
- Instruments Family EUDAMEDComposite Instrument, Long Extra Thin Blade FDA UDI
- Model / Reference
- TN005 EUDAMEDFDA UDI
- Description
- Composite Instrument, Long Extra Thin Blade FDA UDI
Identifiers
- Catalog Number
- TN005 FDA UDI
- Primary DI / UDI-DI
- 00810038094762 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809InstrumentsTFTF EUDAMED
- FDA Product Code
- EIY FDA UDI
- EMDN Code
- L159013 DENTAL SPATULAS, REUSABLE EUDAMED
- GMDN Term
- Dental restoration carver, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Composite Instrument by Garrison Dental Solutions LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081003809InstrumentsTFTF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (2)
- EUDAMED 0e738072-82b8-4b70-8098-cfaa6482f144 61 fields · synced Jun 19, 2026
- FDA UDI 5a9ff0b7-1908-45a8-b323-2872f66447b4 35 fields · synced May 30, 2026