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Mouth Prop with Tongue Guard S
EUDAMEDFDA UDIClass I (EU MDR)
Ref 14677Model DENTAL RETRACTORS
Identity
- Trade Name
- Mouth Prop with Tongue Guard S EUDAMEDNA FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Retractors EUDAMEDUse to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure. FDA UDI
- Model / Reference
- DENTAL RETRACTORS EUDAMED14677 EUDAMEDFDA UDI
- Description
- Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure. FDA UDI
Identifiers
- Catalog Number
- 14677 FDA UDI
- Primary DI / UDI-DI
- 04963931146772 EUDAMEDFDA UDI
- Basic UDI-DI
- 4963931YDM00002WG EUDAMED
- FDA Product Code
- EIG FDA UDI
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Dental cheek retractor, professional, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mouth Prop with Tongue Guard S by Ydm 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 | 4963931YDM00002WG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ydm Corporation
- EUDAMED SRN
- JP-MF-000011653
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED af86824d-f5dc-4b13-b127-563532347969 61 fields · synced Jul 9, 2026
- FDA UDI 45f3f17d-d91c-4fb9-8282-989862031a39 35 fields · synced May 30, 2026