Identity
- Trade Name
- Composi-Tight® 3D Fusion™ Sectional Matrix Kit EUDAMEDComposi-Tight® FDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- Bands Family EUDAMED3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
- Model / Reference
- FX-KFF-01 EUDAMEDFDA UDI
- Description
- 3D Fusion™ Sectional Matrix System: (70) Full Curve Matrices, (80) Wedges, (1) FX400 Short Ring, (1) FX500 Tall Ring, (1) FX600 Wide Prep Ring, (1) Ring Placement Forceps, (1) Matrix Forceps FDA UDI
Identifiers
- Catalog Number
- FX-KFF-01 FDA UDI
- Primary DI / UDI-DI
- 00810038095455 EUDAMEDFDA UDI
- Basic UDI-DI
- 081003809BandsTFXZ EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental 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
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
Category: Dental matrix band kit
Composi-Tight® 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 d6ac4e15-f14f-4901-aba7-7f55387ed2f5 35 fields · synced Jun 18, 2026
- EUDAMED 73ac70fd-74a8-4f89-8613-c48338b467aa 61 fields · synced Jun 18, 2026