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NiTin™ Sectional Matrix Rings
EUDAMEDFDA UDIClass I (EU MDR)
Ref NTG500Ref NT500-1Ref NT400
Identity
- Trade Name
- NiTin™ Sectional Matrix Rings EUDAMEDNiTin™ FDA UDI
- Generic Name
- Dental matrix band retainer FDA UDI
- Device Name
- Rings Family EUDAMEDStandard Ring, Premolar, White FDA UDI
- Model / Reference
- NTG500 EUDAMEDNT500-1 EUDAMEDFDA UDINT400 EUDAMED
- Description
- Standard Ring, Premolar, White FDA UDI
Identifiers
- Catalog Number
- NT500-1 FDA UDI
- Primary DI / UDI-DI
- 10810038094660 EUDAMED00810038094632 EUDAMEDFDA UDI10810038094622 EUDAMED
- Basic UDI-DI
- 081003809RingsTFCH EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band retainer 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
No
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
NiTin™ Sectional Matrix Rings 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 | 081003809RingsTFCH | 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 (4)
- EUDAMED 843740e2-3000-4b2a-8ff2-0e3a3f72069e 61 fields · synced Jul 27, 2026
- EUDAMED 37e2e04e-6868-4274-a7a0-45f3b8f1843b 61 fields · synced May 18, 2026
- EUDAMED 739811f6-1771-450a-9829-0bb9077a41b4 61 fields · synced May 19, 2026
- FDA UDI 3e7304f3-86bc-40f2-bf22-3f1df658794e 35 fields · synced May 29, 2026