MARK3

Enamel Care 5% Sodium Fluoride Varnish Assorted Pack B.Gum, Caramel, Mint & Straw. w/TCP 200/bx.- MARK3

Registry build 21.09.26
1manufacturer
11catalogue numbers in this listing

Who Else Makes It

Registered in Hebei.

Chinese manufacturers registered for FDA product code LBH
Manufacturer City Province Registered as Device types
CAO (China) Medical Equipment Company, Limited Langfang Hebei Contract manufacturer 6

Record

Regulatory record for MARK3
Listed by Cargus International, Inc
FDA product code LBH
Device type Varnish, Cavity
Device class Class 2
Regulation 21 CFR 872.3260
Record published 2021-07-01
Record revised 2022-11-21 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Storage Storage environment temperature 68 to 75 °F
Packaging Box of 50, box of 12

Catalogue Numbers

Catalogue numbers for MARK3
Catalogue number Size Per pack Status
1680 50 In distribution
1652 In distribution
7102 50 In distribution
1686 50 In distribution
7100 50 In distribution
1681 50 In distribution
7101 50 In distribution
1654 In distribution
1689 50 In distribution
1683 50 In distribution
1650 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
NovaBright Nanova BIO Materials Inc 46
Enamelast Ultradent Products Inc. 41
Nupro® Dentsply Professional 34
Fluorodose Centrix, Inc. 26
VarnishAmerica Medical Products Laboratories, Inc. 24
Voco Profluorid Varnish Voco Gmbh 23
Profisil Kettenbach Gmbh & Co KG 23
Starbright Nanova BIO Materials Inc 22
Wonderful Dental Roses and Rubies, LLC 19
Henry Schein Henry Schein, Inc. 19
Waterpik Ultra Thin & Clear Varnish Water PIK, Inc. 18
Premier Premier Dental Products Co. 17

Showing 12 of 282. All products under Varnish, Cavity

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer