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maximat plus pre-loaded
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5123Ref S01067Ref S01066
Identity
- Trade Name
- maximat plus pre-loaded EUDAMEDFDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- RETAINERS AND SPOOLS EUDAMEDmetal matrices 0.04 mm / 5.5 mm FDA UDI
- Model / Reference
- 5123 EUDAMEDFDA UDIS01067 EUDAMEDS01066 EUDAMED
- Description
- metal matrices 0.04 mm / 5.5 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- +E29951230 EUDAMED+E299S010670 EUDAMED+E299S010660 EUDAMEDE29951230 FDA UDI
- Basic UDI-DI
- ++E299RETAINERANDSPOOLSBQ 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
maximat plus pre-loaded 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 | ++E299RETAINERANDSPOOLSBQ | 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 (4)
- EUDAMED a92c8341-04f9-410d-ae9a-20d56383898c 61 fields · synced Jul 29, 2026
- EUDAMED 3f9a2f01-cf50-4167-b495-5086f3b14826 61 fields · synced May 17, 2026
- EUDAMED 05c087e2-f7d4-4d03-89fb-7ace6f8a58a9 61 fields · synced May 19, 2026
- FDA UDI 33c71bcb-5bed-4bb8-8970-e88466cecd85 34 fields · synced May 30, 2026