← Back to catalogue

Medicom Duraflor Ultra

FDA UDI

Class II (US FDA UDI)

by AMD Medicom Inc

Identity

Trade Name
MEDICOM DURAFLOR ULTRA FDA UDI
Generic Name
Dental coating, tooth-desensitizing, professional FDA UDI
Device Name
DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE FDA UDI
Model / Reference
1016-ST30 FDA UDI
Description
DURAFLOR ULTRA VARNISH 5% FLUORIDE STRAWBERRY -DOSE FDA UDI

Identifiers

Catalog Number
1016-ST30 FDA UDI
Primary DI / UDI-DI
10686864040986 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 — 0.4 Milliliter FDA UDI

Category: Dental coating, tooth-desensitizing, professional

Medicom Duraflor Ultra 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
AMD Medicom Inc

Sources (1)

  • FDA UDI 433222e4-74ba-498d-90a9-4270d50feec8 37 fields · synced May 31, 2026