← Back to catalogue
NiTin™ Sectional Matrix System Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref NTGK01Ref NT-KMN-01
Identity
- Trade Name
- NiTin™ Sectional Matrix System Kit EUDAMEDNiTin™ Sectional Matrix Kit EUDAMEDNiTin Garrison® FDA UDINiTin™ FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDIDental matrix band kit FDA UDI
- Device Name
- Bands Family EUDAMEDFull Curve Matrix Band Kit: 250 Count (50 of Each Size) FDA UDISectional Matrix Kit: (100) Full Curve Matrices, (100) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps, (1) Band Forceps FDA UDI
- Model / Reference
- NTGK01 EUDAMEDFDA UDINT-KMN-01 EUDAMEDFDA UDI
- Description
- Full Curve Matrix Band Kit: 250 Count (50 of Each Size) FDA UDISectional Matrix Kit: (100) Full Curve Matrices, (100) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps, (1) Band Forceps FDA UDI
Identifiers
- Catalog Number
- NTGK01 FDA UDINT-KMN-01 FDA UDI
- Primary DI / UDI-DI
- 00810038095813 EUDAMEDFDA UDI00810038095943 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMEDQ01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDIDental matrix band kit 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
NiTin™ Sectional Matrix System Kit 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 | 081003809BandsTFXZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Garrison Dental Solutions LLC
- EUDAMED SRN
- US-MF-000004112
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (4)
- EUDAMED 3af664ea-c254-4a0c-9a35-fc96436cf77d 61 fields · synced Jul 13, 2026
- FDA UDI 414150ad-4353-4b96-9325-883d0c6c689a 35 fields · synced May 29, 2026
- FDA UDI 66169ec8-a6b5-4e37-9b8a-ae377faf7950 35 fields · synced May 30, 2026
- EUDAMED eb23da17-3996-4ef3-a02c-d7d538cb0dc3 61 fields · synced Jul 13, 2026