Hydroxyline

HYDROXYLINE TC (Tooth Color) - Calcium Hydroxide Cavity Liner is a thin 'varnish' film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in…

Registry build 21.09.26

HYDROXYLINE TC (Tooth Color) – Calcium Hydroxide Cavity Liner is a thin ‘varnish’ film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and ‘pulp’ shock. HYDROXYLINE TC is a dentin colored film which maintains the composite resins’ esthetics for thin Class V restorations.

1manufacturer
8catalogue 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 Hydroxyline
Listed by Taub Products
FDA product code EJK
Device type Liner, Cavity, Calcium Hydroxide
Device class Class 2
Regulation 21 CFR 872.3250
Premarket notification Exempt
Record published 2016-10-26
Record revised 2025-07-14 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: Keep away from open flame. See SDS.
Sizes Total volume 6 to 50 ml

Catalogue Numbers

Catalogue numbers for Hydroxyline
Catalogue number Size Status
Thinner – 50cc (2 oz) Total Volume 50 ml In distribution
Kit – White Total Volume 6 ml In distribution
Thinner – 12cc Total Volume 12 ml In distribution
Liquid Base – White – 6cc Total Volume 6 ml In distribution
Liquid Base – TC – 6cc Total Volume 6 ml In distribution
Thinner – TC – 50cc (2 oz) Total Volume 50 ml In distribution
Kit – TC Total Volume 6 ml In distribution
Thinner – TC – 12cc Total Volume 12 ml 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
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
UltraCal XS Ultradent Products 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