Identity
- Trade Name
- Lip & Cheek Retractor Set EUDAMEDDENTECH FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- Mouth Opener EUDAMEDLip & Cheek Retractor Set FDA UDI
- Model / Reference
- 50570131 EUDAMEDFDA UDI
- Description
- Lip & Cheek Retractor Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560218668561 EUDAMEDFDA UDI
- Basic UDI-DI
- 456021866dentech1338001PE EUDAMED
- FDA Product Code
- EIF FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Bulgaria 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
Lip & Cheek Retractor Set by Dentech Corporation — 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 | 456021866dentech1338001PE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentech Corporation
- EUDAMED SRN
- JP-MF-000046690
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 1ceadf5d-b304-4e71-93e5-52a60a9a7af9 61 fields · synced Jun 20, 2026
- FDA UDI d4a832e5-2cd0-435d-a4c8-5b97e9ddaabc 33 fields · synced May 30, 2026