Stoma®

FDA UDI

Class I (US FDA UDI)

by Storz am Mark GmbH

Identity

Trade Name: STOMA® FDA UDI
Generic Name: Dental matrix band tensioner FDA UDI
Device Name: Matrix retainer, Tofflemire-Senior FDA UDI
Model / Reference: 3421.22 FDA UDI
Description: Matrix retainer, Tofflemire-Senior FDA UDI

Identifiers

Catalog Number: 3421.22 FDA UDI
Primary DI / UDI-DI: ESAM3421221 FDA UDI
FDA Product Code: JEP FDA UDI
GMDN Term: Dental matrix band tensioner 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental matrix band tensioner

Stoma® by Storz am Mark GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Palodent® Plus Sectional Matrix System — Dentsply International · Class I
Hahnenkratt — E. Hahnenkratt GmbH · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
Palodent® Plus Sectional Matrix System — Dentsply International · Class I

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: Storz am Mark GmbH

Sources (1)

FDA UDI 5923b265-bf69-4abf-acdb-0e7249dc0255 35 fields · synced Jun 1, 2026