Katana Cleaner

2 catalogue numbers from #3970-KA, listed by Kuraray Noritake Dental, Inc., United States, under Varnish, Cavity. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
2catalogue 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 Katana Cleaner
Listed by Kuraray Noritake Dental, Inc., United States
FDA product code LBH
Device type Varnish, Cavity
Device class Class 2
Regulation 21 CFR 872.3260
510(k) K191133
Record published 2019-12-10
Record revised 2021-08-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Katana Cleaner
Catalogue number Size Status
#3970-KA In distribution
#3971-KA 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