Identity
- Trade Name
- STOMA® FDA UDI
- Generic Name
- Dental matrix band, reusable FDA UDI
- Device Name
- Matrix band, 5mm, 5m long FDA UDI
- Model / Reference
- 3435.05 FDA UDI
- Description
- Matrix band, 5mm, 5m long FDA UDI
Identifiers
- Catalog Number
- 3435.05 FDA UDI
- Primary DI / UDI-DI
- ESAM3435051 FDA UDI
- FDA Product Code
- JEP FDA UDI
- GMDN Term
- Dental matrix band, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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, reusable
Stoma® by Storz am Mark GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band, reusable.
- Hahnenkratt — E. Hahnenkratt GmbH · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- Walser® matrices — Dr. Walser Dental GmbH · Class I
- Denovo Preformed Matrix strip — DENOVO DENTAL INC · Class I
- Denovo Preformed Matrix Band — DENOVO DENTAL INC · Class I
- Denovo Preformed Matrix Band — DENOVO DENTAL INC · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Denovo Preformed Matrix Band — DENOVO DENTAL INC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Storz am Mark GmbH
Sources (1)
- FDA UDI 42fd550f-1a81-4e45-a0f8-33ba36072167 35 fields · synced Jun 8, 2026