Identity
- Trade Name
- Denovo Preformed Matrix Band FDA UDI
- Generic Name
- Dental matrix band, reusable FDA UDI
- Device Name
- Adult MX Bands #11 EUDAMEDDenovo Preformed Matrix Band - Adult 1/4, Size 11 FDA UDI
- Model / Reference
- 170-411 EUDAMEDFDA UDI
- Description
- Denovo Preformed Matrix Band - Adult 1/4, Size 11 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810059294868 EUDAMED00810059291072 FDA UDI
- Basic UDI-DI
- B-00810059294868 EUDAMED
- FDA Product Code
- JEP FDA UDI
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, reusable 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
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band, reusable
Denovo Preformed Matrix Band by Denovo Dental Inc — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band, reusable.
- Hahnenkratt — E. Hahnenkratt GmbH · Class I
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- Reicodent — devemed GmbH · Class I
- Walser® matrices — Dr. Walser Dental GmbH · Class I
- Hahnenkratt — E. Hahnenkratt GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Denovo Dental Inc
Sources (2)
- FDA UDI a7e5f246-ed8f-4d94-8ae6-87f624d386bd 33 fields · synced Sep 30, 2026
- EUDAMED d56a1b5f-063c-4864-a57a-4165a9b6e803 61 fields · synced Sep 17, 2026