Composi-Tight®

FDA UDI

Class I (US FDA UDI)

by Garrison Dental Solutions, L.l.c.

Identity

Trade Name: Composi-Tight® FDA UDI
Generic Name: Dental matrix band, single-use FDA UDI
Device Name: 3D Fusion™ Firm Matrix Band Sample Kit: 15 Count (4) FXH100, (4) FXH175, (4) FXH200, (3) FXH300 FDA UDI
Model / Reference: FXHBS01 FDA UDI
Description: 3D Fusion™ Firm Matrix Band Sample Kit: 15 Count (4) FXH100, (4) FXH175, (4) FXH200, (3) FXH300 FDA UDI

Identifiers

Catalog Number: FXHBS01 FDA UDI
Primary DI / UDI-DI: 00810038095387 FDA UDI
FDA Product Code: JEP FDA UDI
GMDN Term: Dental matrix band, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental matrix band, single-use

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
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 (1)

FDA UDI db8435e7-f112-48c6-bf97-fda14ded6f93 35 fields · synced Jun 1, 2026