Identity
- Trade Name
- Tongue-Away Sheild FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- Medium FDA UDI
- Model / Reference
- 100-391 FDA UDI
- Description
- Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192029049402 FDA UDI
- FDA Product Code
- FMA FDA UDI
- GMDN Term
- Dental cheek retractor, professional, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6230 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental cheek retractor, professional, reusable
Tongue-Away Sheild by Tp Orthodontics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cheek retractor, professional, reusable.
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- GoldenDent — GoldenDent · Class I
- Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
- Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
- Power Dental USA — Power Dental USA, Inc. · 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 |
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Manufacturer
- Manufacturer
- Tp Orthodontics, Inc.
Sources (1)
- FDA UDI c09ec2ee-73b4-46c8-9ad5-211fae7dd1d6 34 fields · synced May 30, 2026