Helioseal Clear F F Plus

Helioseal F Plus Cavifil Refill 50x0.1g

Registry build 21.09.26
1manufacturer
8catalogue numbers in this listing

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code EBC
Manufacturer City Province Registered as Device types
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7

Record

Regulatory record for Helioseal Clear F F Plus
Listed by Ivoclar Vivadent Aktiengesellschaft
FDA product code EBC
Device type Sealant, Pit And Fissure, And Conditioner
Device class Class 2
Regulation 21 CFR 872.3765
Record published 2019-11-05
Record revised 2023-09-01 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 10

Catalogue Numbers

Catalogue numbers for Helioseal Clear F F Plus
Catalogue number Size Per pack Status
686769AN In distribution
686769AN In distribution
686771AN 50 In distribution
686770AN 5 In distribution
558521AN In distribution
686770AN 5 In distribution
686771AN 50 In distribution
686772AN In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
UltraSeal XT Ultradent Products Inc. 22
SciPharm Pit & Fissure Sealer Bonding Agent Scientific Pharmaceuticals, Inc. 20
Orthosource Orthosource, Inc. 20
Visalys Fill Kettenbach Gmbh & Co KG 14
Riva Protect SDI Ltd. 14
Venus Diamond Flow Kulzer SRL 9
Conseal SDI Ltd. 9
Delton® Dentsply Professional 9
Patterson® Patterson Dental Supply, Inc. 8
Clinpro™ 3M Company 7
Visalys Flow Kettenbach Gmbh & Co KG 7
Enamel Coating Resin Rizhao Huge Biomaterials Company, Ltd. 6

Showing 12 of 133. All products under Sealant, Pit And Fissure, And Conditioner

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