← Back to catalogue

Premier

FDA UDI

Class II (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name
Premier FDA UDI
Generic Name
Dental cavity varnish FDA UDI
Device Name
EP Varnish Straw 'N Cream .40 ml (bulk) FDA UDI
Model / Reference
9007549 FDA UDI
Description
EP Varnish Straw 'N Cream .40 ml (bulk) FDA UDI

Identifiers

Primary DI / UDI-DI
D6919007549 FDA UDI
510(k) Number
K062683 FDA UDI
FDA Product Code
LBH FDA UDI
GMDN Term
Dental cavity varnish 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

No

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

Yes

FDA UDI

Category: Dental cavity varnish

Premier by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cavity varnish.

Cleared under the same submission

K062683 also covers:

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
Premier Dental Products Company

Sources (1)

  • FDA UDI e379d972-dd5e-4458-8602-f4a91962c670 34 fields · synced May 30, 2026