Identity
- Trade Name
- Topex® FDA UDI
- Generic Name
- Fluoride gel tray FDA UDI
- Device Name
- Topex® Dual Arch Tray Small Bag of 50 FDA UDI
- Model / Reference
- AD32010 FDA UDI
- Description
- Topex® Dual Arch Tray Small Bag of 50 FDA UDI
Identifiers
- Catalog Number
- AD32011 FDA UDI
- Primary DI / UDI-DI
- D687AD320111 FDA UDI
- FDA Product Code
- KMT FDA UDI
- GMDN Term
- Fluoride gel tray FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluoride gel tray
Topex® by Sultan Healthcare Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluoride gel tray.
- NUPRO® — Dentsply Professional · Class I
- Health-Tec/DHP Fluoride Trays — Dental Health Products Inc · Class I
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- SCOTT'S DUAL ARCH TRAYS 100/bag MEDIUM (WHITE) — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Vista Single Small Fluoride Trays — Vista Dental · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Health-Tec/DHP Fluoride Trays — Dental Health Products Inc · Class I
- MEDICOM DENTICARE PRO-TRAY — AMD Medicom 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
- Sultan Healthcare Inc
Sources (1)
- FDA UDI fe392617-fa45-4712-92db-f55ef46c1492 34 fields · synced May 30, 2026