Identity
- Trade Name
- MEDICOM DURAFLOR FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- DURAFLOR VARNISH 5% FLUORIDE SAMPLE PACK FDA UDI
- Model / Reference
- SP-1011 FDA UDI
- Description
- DURAFLOR VARNISH 5% FLUORIDE SAMPLE PACK FDA UDI
Identifiers
- Catalog Number
- SP-1011 FDA UDI
- Primary DI / UDI-DI
- 20686864041034 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.25 Milliliter FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Medicom Duraflor by AMD Medicom Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing, professional.
- Profisil — Kettenbach GmbH & Co. KG · Class II
- Profisil — Kettenbach GmbH & Co. KG · Class II
- Wonderful Dental — Roses and Rubies, LLC · Class II
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class II
- SurgiMac — Surgimac LLC · Class II
- TastyTooth — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Wonderful Dental — Roses and Rubies, LLC · Class II
- Colgate PreviDent Varnish Mint — COLGATE ORAL PHARMACEUTICALS, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMD Medicom Inc
Sources (1)
- FDA UDI cdf2cf7f-6e35-4e5f-8e95-b40e34662fb7 36 fields · synced Jun 8, 2026