Identity
- Trade Name
- myTines Medium EUDAMEDFDA UDI
- Generic Name
- Dental matrix band retainer FDA UDI
- Device Name
- DENTAL RINGS EUDAMED
- Model / Reference
- M01894 EUDAMED6303 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +E299M018940 EUDAMED+E29963030 EUDAMEDE29963030 FDA UDI
- Basic UDI-DI
- ++E299DENTALRINGSM6 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental matrix band retainer 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental appliance fabrication material, ceramic
myTines Medium by Polydentia SA — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++E299DENTALRINGSM6 | 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 (3)
- EUDAMED 04a021ac-3137-42cd-af33-f520eeb74e5b 61 fields · synced Jul 15, 2026
- EUDAMED f9e66966-3566-44d2-9e79-654352b13607 61 fields · synced May 18, 2026
- FDA UDI 16474dac-e1e5-4fea-8e4f-cd1826a39d7c 33 fields · synced May 30, 2026