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Lumicontrast sectional matrices
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6706Ref S01676Ref S01677Ref S01679
Identity
- Trade Name
- Lumicontrast sectional matrices EUDAMEDFDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- METAL MATRICES EUDAMED0.04 mm / 6.4 mm, 70 pcs. FDA UDI
- Model / Reference
- 6706 EUDAMEDFDA UDIS01676 EUDAMEDS01677 EUDAMEDS01679 EUDAMED
- Description
- 0.04 mm / 6.4 mm, 70 pcs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29967060 EUDAMED+E299S016760 EUDAMED+E299S016770 EUDAMED+E299S016790 EUDAMEDE29967060 FDA UDI
- Basic UDI-DI
- ++E299METALMATRICESM6 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental matrix band, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Liechtenstein 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Lumicontrast sectional matrices by Polydentia 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 | ++E299METALMATRICESM6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Polydentia SA
- EUDAMED SRN
- CH-MF-000008779
- Authorised Representative
- IDD International Dental Distributors AG LI-AR-000008367
Sources (5)
- EUDAMED 68c5a824-b906-4366-9396-26f3a6dfde78 61 fields · synced Jul 23, 2026
- EUDAMED dc414ce4-c8ec-49c2-97d9-31d4d9e2c200 61 fields · synced May 16, 2026
- EUDAMED 964307a0-743e-4377-8986-f53506cb1ad3 61 fields · synced May 17, 2026
- EUDAMED 67623518-8263-432c-8fed-9b337ef1962d 61 fields · synced May 18, 2026
- FDA UDI 6c067585-94f6-437c-b656-1868295e5af0 34 fields · synced May 30, 2026