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NiTin™ Sectional Matrix Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref NTMK01Ref NTG-MMG-00Ref NTG-KMG-40Ref NT-KMN-40Ref NT-MMN-00Ref NT-KMN-35Ref NTK4-M
Identity
- Trade Name
- NiTin™ Sectional Matrix Kit EUDAMEDNiTin™ FDA UDINiTin Garrison® FDA UDI
- Generic Name
- Dental matrix band kit FDA UDIDental matrix band, single-use FDA UDIDental wedge, single-use FDA UDI
- Device Name
- Bands Family EUDAMEDWedges Family EUDAMEDSectional Matrix Mini Kit: (40) Full Curve Matrices, (40) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Kit: (40) Full Curve Matrices, (40) Wedges, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Trial Kit: (25) Full Curve Matrices, (20) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDIFull Curve Matrix Band Kit: 250 Count (50 of Each Size) FDA UDIWedge Assortment Kit: 200 Count (50 of Each Size) FDA UDISectional Matrix Trial Kit: (25) Full Curve Matrices, (20) Wedges, (1) NTG400 Ring, (1) NTG500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Mini Kit: (40) Full Curve Matrices, (40) Wedges, (1) NTG400 Ring, (1) NTG500 Ring, (1) Ring Placement Forceps FDA UDI
- Model / Reference
- NTMK01 EUDAMEDFDA UDINT-KMN-40 EUDAMEDFDA UDINT-KMN-35 EUDAMEDFDA UDINT-MMN-00 EUDAMEDFDA UDINTK4-M EUDAMEDFDA UDINTG-MMG-00 EUDAMEDFDA UDINTG-KMG-40 EUDAMEDFDA UDI
- Description
- Sectional Matrix Mini Kit: (40) Full Curve Matrices, (40) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Kit: (40) Full Curve Matrices, (40) Wedges, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Trial Kit: (25) Full Curve Matrices, (20) Wedges, (1) NT400 Ring, (1) NT500 Ring, (1) Ring Placement Forceps FDA UDIFull Curve Matrix Band Kit: 250 Count (50 of Each Size) FDA UDIWedge Assortment Kit: 200 Count (50 of Each Size) FDA UDISectional Matrix Trial Kit: (25) Full Curve Matrices, (20) Wedges, (1) NTG400 Ring, (1) NTG500 Ring, (1) Ring Placement Forceps FDA UDISectional Matrix Mini Kit: (40) Full Curve Matrices, (40) Wedges, (1) NTG400 Ring, (1) NTG500 Ring, (1) Ring Placement Forceps FDA UDI
Identifiers
- Catalog Number
- NT-KMN-40 FDA UDINT-KMN-35 FDA UDINT-MMN-00 FDA UDINTMK01 FDA UDINTK4-M FDA UDINTG-MMG-00 FDA UDINTG-KMG-40 FDA UDI
- Primary DI / UDI-DI
- 00810038096001 EUDAMEDFDA UDI00810038095981 EUDAMEDFDA UDI00810038095967 EUDAMEDFDA UDI00810038096018 EUDAMEDFDA UDI00810038095936 EUDAMEDFDA UDI00810038095882 EUDAMEDFDA UDI00810038095837 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED081003809WedgesTFZH EUDAMED
- FDA Product Code
- JEP FDA UDIEJB 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 kit FDA UDIDental matrix band, single-use FDA UDIDental 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
No
FDA UDIFDA 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 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 |
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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 (14)
- EUDAMED c4fe4fed-2d1f-4173-863c-8b5b40ceb78c 61 fields · synced Jul 31, 2026
- FDA UDI f7cef364-7163-47dc-a012-341034073fae 35 fields · synced May 29, 2026
- FDA UDI 7ac6961e-4c0b-4f36-88ec-14083f3836e3 35 fields · synced May 30, 2026
- FDA UDI 9be742a1-0117-4808-bc24-0850fdd80d51 35 fields · synced May 30, 2026
- FDA UDI e20afbb2-e27a-4405-9f1d-cd00fa3e3e71 35 fields · synced May 30, 2026
- FDA UDI 495751f4-e292-4cfb-976b-4e34381f47ce 35 fields · synced May 30, 2026
- FDA UDI fc1069fb-5ec7-4a2c-8397-426f0f90f09b 35 fields · synced May 30, 2026
- FDA UDI 36afab18-ccee-4ece-93b9-e99ceb2c955e 35 fields · synced May 30, 2026
- EUDAMED e43911af-3bff-4c81-ab41-7d2f67df045b 61 fields · synced Jul 10, 2026
- EUDAMED 918d4998-77a9-40c2-b44f-38ef2c62340c 61 fields · synced Jul 13, 2026
- EUDAMED 940b8468-4ea5-4255-8aaa-2ad92051bf7d 61 fields · synced Jul 15, 2026
- EUDAMED 48faa859-db0e-4274-adca-95d703c2386d 61 fields · synced Jul 19, 2026
- EUDAMED fd406897-f08a-4db5-8138-15dc5a87af6f 61 fields · synced Jul 22, 2026
- EUDAMED 44c64cf3-5f1d-44fc-ab66-8ce36c7f81ce 61 fields · synced Jul 31, 2026