Nanodent

Tooth Desensitizer

Registry build 21.09.26
1manufacturer
1catalogue number
1510(k) clearance

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 Nanodent
Listed by Phoenix Dental, Inc., United States
FDA product code LBH
Device type Varnish, Cavity
Device class Class 2
Regulation 21 CFR 872.3260
Record published 2022-07-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, expiry date
Storage Special storage condition: Store at room temperature. Do not refrigerate.
Sizes Total volume 4.5 ml

Catalogue Numbers

Catalogue numbers for Nanodent
Catalogue number Size Status
0001 Total Volume 4.5 ml 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K120109 2012-03-07

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