Identity
- Trade Name
- Ortho Tongue scraper Silver FDA UDI
- Generic Name
- Tongue scraper, reusable FDA UDI
- Device Name
- Manual Tongue Scraper FDA UDI
- Model / Reference
- 10000001 FDA UDI
- Description
- Manual Tongue Scraper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810131040529 FDA UDI
- FDA Product Code
- LCN FDA UDI
- GMDN Term
- Tongue scraper, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tongue scraper, reusable
Ortho Tongue scraper Silver by Supermouth LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tongue scraper, reusable.
- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class I
- Walgreens — WALGREEN CO. · Class I
- Perfora — CHIPPER CONSUMER PRIVATE LIMITED · Class I
- Plastic Tongue Cleaners — PRACTICON, INC. · Class I
- Dentemp Oral Care Kit — Doc Brands, Inc. · Class I
- TopCare — Topco Associates, LLC · Class I
- GUM® — SUNSTAR AMERICAS, INC. · Class I
- Ortho Resuable Tongue Scraper Silver — Supermouth LLC · 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
- Supermouth LLC
Sources (1)
- FDA UDI e13aca97-1ec4-4ffd-a11a-690084df5536 33 fields · synced Jun 6, 2026