Identity
- Trade Name
- ODUS Universal Strips Curved, 6mm EUDAMEDTRANSPARENT ODUS UNIVERSAL STRIPS CURVED, 6 mm FDA UDI
- Generic Name
- Dental matrix band, reusable FDA UDI
- Device Name
- Transparent Strips EUDAMEDTransparent strips are matrices which help contour restorative materials to match natural dentition (generally light-cured composite on anterior tooth). Transparent strips are made of Biaxially-oriented Polyethylene terephthalate (Bo-PET) films. The products are used in the dentistry field. Pack of 50 FDA UDI
- Model / Reference
- 43711d EUDAMEDFDA UDI
- Description
- Transparent strips are matrices which help contour restorative materials to match natural dentition (generally light-cured composite on anterior tooth). Transparent strips are made of Biaxially-oriented Polyethylene terephthalate (Bo-PET) films. The products are used in the dentistry field. Pack of 50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159161875 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916TRANSP_STRIPSQC EUDAMED
- FDA Product Code
- EHM FDA UDI
- EMDN Code
- Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- France 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
ODUS Universal Strips Curved, 6mm by Produits Dentaires SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764015916TRANSP_STRIPSQC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED de66287e-a863-426e-9160-629627e81078 61 fields · synced Jul 10, 2026
- FDA UDI 9c8b8bf6-d142-41c7-800f-2833722f4a7d 34 fields · synced May 30, 2026