Identity
- Trade Name
- Retractor - Tongue and Cheek FDA UDI
- Generic Name
- Hand-held dental retractor FDA UDI
- Device Name
- Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area FDA UDI
- Model / Reference
- Retractor T&C Large FDA UDI
- Description
- Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area FDA UDI
Identifiers
- Catalog Number
- Retractor T&C Large FDA UDI
- Primary DI / UDI-DI
- 00083208130243 FDA UDI
- FDA Product Code
- EIG FDA UDI
- GMDN Term
- Hand-held dental retractor FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Hand-held dental retractor
Retractor - Tongue and Cheek by Suncoast Dental, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held dental retractor.
- Power Dental USA — Power Dental USA, Inc. · Class I
- devemed — devemed GmbH · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- ACE — ACE SURGICAL SUPPLY CO., INC. · Class I
- STOMA® — Storz am Mark GmbH · Class I
- DIOnavi. Scan Retractor Lower jaw — DIO Corporation · Class I
- EXPANDER — KLS-Martin L.P. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suncoast Dental, Inc.
Sources (1)
- FDA UDI 0c272bad-4109-4c14-aa11-ab88f05738dc 35 fields · synced Jun 1, 2026