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Composi-Tight 3D Fusion Sectional Matrix System
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref FX-KFF-00-VM
Identity
- Trade Name
- Composi-Tight® 3D Fusion™ Sectional Matrix Kit EUDAMEDComposi-Tight 3D Fusion Sectional Matrix System FDA UDI
- Generic Name
- Dental matrix band kit FDA UDI
- Device Name
- Bands Family EUDAMED1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fusion wedges (20 each), 1 FXP01, 4x Varistrips, 5x Margin Elevation bands FDA UDI
- Model / Reference
- FX-KFF-00-VM EUDAMEDFDA UDI
- Description
- 1 FX400 ring, 1 FX500 ring, 1 FX600 ring, 70 Fusion bands (20/5/20/20/5), 80 Fusion wedges (20 each), 1 FXP01, 4x Varistrips, 5x Margin Elevation bands FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810038090450 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental matrix band kit
Composi-Tight 3D Fusion Sectional Matrix System by Garrison Dental Solutions, L.l.c. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Dental matrix band kit.
- Premier X5 Sectional Matrix System — PREMIER DENTAL PRODUCTS COMPANY · Class I
- Dual-Force™ Sectional Matrix System Ring Forceps — Den-Mat Holdings, LLC · Class I
- HD Anterior Matrix Kit — Bioclear Matrix Systems, LLC
- Dual-Force™ Sectional Matrix System Starter Kit w/ Ultra-Wrap — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Biofit HD Posterior Kit — Bioclear Matrix Systems, LLC
- Evolve Matrix Procedure Kit — Bioclear Matrix Systems, LLC
- Dual-Force™ Sectional Matrix System Complete Kit w/Ultra-Wrap — Den-Mat Holdings, LLC · Class I
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 2a03d10e-f85c-4ebd-9909-038f46849e17 34 fields · synced Jun 19, 2026
- EUDAMED 4b051543-0b59-4452-b11b-3f2165f6519a 61 fields · synced Jun 19, 2026