Composi-Tight 3D Fusion

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref FX-HHF-50

by Garrison Dental Solutions, L.l.c.

Identity

Trade Name: Composi-Tight® 3D Fusion™ Sectional Matrix Kit EUDAMED
Composi-Tight 3D Fusion FDA UDI
Generic Name: Dental matrix band kit FDA UDI
Device Name: Bands Family EUDAMED
Composi-TIght 3D Fusion Firm Intro Kit FDA UDI
Model / Reference: FX-HHF-50 EUDAMEDFDA UDI
Description: Composi-TIght 3D Fusion Firm Intro Kit FDA UDI

Identifiers

Catalog Number: FX-HHF-50 FDA UDI
Primary DI / UDI-DI: 00810038090221 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

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental matrix band kit

Composi-Tight 3D Fusion by Garrison Dental Solutions, L.l.c. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental matrix band kit.

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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 659d3c91-6eb9-4db2-81cf-d75835b48ce6 35 fields · synced Jun 19, 2026
EUDAMED 3f0d5f51-e389-438b-81b7-c1b7f3a791b2 61 fields · synced Jun 14, 2026