Identity
- Trade Name
- NiTin™ Sectional Matrix Kit EUDAMEDNiTin™ FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Wedges Family EUDAMEDWedge Assortment Kit: 400 Count (100 of Each Size) FDA UDI
- Model / Reference
- NTK4 EUDAMEDFDA UDI
- Description
- Wedge Assortment Kit: 400 Count (100 of Each Size) FDA UDI
Identifiers
- Catalog Number
- NTK4 FDA UDI
- Primary DI / UDI-DI
- 00810038095929 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809WedgesTFZH EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental wedge, single-use 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
Yes
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
Category: Dental wedge, single-use
NiTin™ by Garrison Dental Solutions, L.l.c. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Garrison Dental Solutions, L.l.c.
Sources (2)
- FDA UDI fda23f89-4dc6-4e40-91eb-0fd91a41ceb3 35 fields · synced Jun 19, 2026
- EUDAMED fa00e2cf-6407-42ff-bb31-1c9c449adf0c 61 fields · synced Jun 19, 2026