Identity
- Trade Name
- TopCare FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- Dental Tool Kit FDA UDI
- Model / Reference
- XES FDA UDI
- Description
- Dental Tool Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00036800442245 FDA UDI
- FDA Product Code
- EAX FDA UDIEMN FDA UDIJET FDA UDILCN FDA UDI
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.6650 FDA UDI872.6855 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual dental scaler, reusableDental mirror, reusablePeriodontal pick/brush, reusableTongue scraper, reusable
TopCare by Topco Associates, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tongue scraper, reusable.
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- Adult SuperScraper Silver — Supermouth LLC · Class I
- Walgreens — WALGREEN CO. · Class I
- Chocolate Kids Tongue Scraper Double Scoops — 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
- Topco Associates, LLC
Sources (1)
- FDA UDI d18f1aaa-ad5e-4af2-bd45-35ba26e184f1 33 fields · synced Jun 1, 2026