Bosworth Hydrox

Cavity Liner 6 pk Base & Catalyst Dentin Kit

Registry build 21.09.26
1manufacturer
4catalogue numbers in this listing

Who Else Makes It

Registered in Guangxi.

Chinese manufacturers registered for FDA product code EJK
Manufacturer City Province Registered as Device types
Guilin Kevin Peter Technology Co., Ltd. Guilin Guangxi Manufacturer 13

Record

Regulatory record for Bosworth Hydrox
Listed by Harry J. Bosworth Co., United States
FDA product code EJK
Device type Liner, Cavity, Calcium Hydroxide
Device class Class 2
Regulation 21 CFR 872.3250
Record published 2016-09-15
Record revised 2018-03-29 (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
Storage Storage environment temperature 0 to 30 °C; Special storage condition: Keep away from moisture; Special storage condition: Keep out of direct sunlight; Storage environment temperature 32 to 86 °F

Catalogue Numbers

Catalogue numbers for Bosworth Hydrox
Catalogue number Size Status
0921074 In distribution
0921071 In distribution
0921072 In distribution
0921073 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Roeko Calcium Hydroxide Plus Points Coltène/Whaledent AG 15
Hygenic Coltene/Whaledent Gmbh & Co. KG 14
Calcigel Prevest Denpro Limited 8
TheraCal LC Bisco, Inc. 8
Hydroxyline Taub Products 8
GC Fuji Lining™ GC America Inc. 7
TheraCal PT Bisco, Inc. 6
Super Seal Phoenix Dental, Inc. 5
Cal LC Prevest Denpro Limited 4
AxioCAL LC Axiodent Inc. 4
Ultra-Blend Plus Ultradent Products Inc. 4
AxioCAL Axiodent Inc. 4

Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide

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