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VeneerNow Injectable Matrix System
FDA UDIEUDAMEDClass I (US FDA UDI)
by Iveneer Ltd
Identity
- Trade Name
- VeneerNow Injectable Matrix System FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- 6(SM) FDA UDI
- Model / Reference
- Premier Refill 8 SM FDA UDI
- Description
- 6(SM) FDA UDI
Identifiers
- Catalog Number
- 9069299 FDA UDI
- Primary DI / UDI-DI
- 07290019259299 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
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental matrix band, single-use
VeneerNow Injectable Matrix System by Iveneer Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band, single-use.
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- Prehma — Keystone Industries · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Cure-Thru Clear Cervical Matrices — PREMIER DENTAL PRODUCTS COMPANY · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Iveneer Ltd
Sources (2)
- FDA UDI 23792294-2b73-46ab-8ba7-c196ce638dc1 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 22, 2026