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: Mallet, Ø 40mm, 720g, withcoated handle, 24cm FDA UDI
Model / Reference: 3313.00 FDA UDI
Description: Mallet, Ø 40mm, 720g, withcoated handle, 24cm FDA UDI

Identifiers

Catalog Number: 3313.00 FDA UDI
Primary DI / UDI-DI: ESAM3313001 FDA UDI
FDA Product Code: FZY FDA UDI
GMDN Term: Dental matrix band tensioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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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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 0944f5b1-1209-4be4-a9cc-6d1360604d11 35 fields · synced May 30, 2026