Interface Ceramic Etch and Silane

Interface Ceramic Etch and Silane: 1 catalogue number listed by Vista Dental, under Agent, Tooth Bonding, Resin. 6 manufacturers in China are registered for this product code.

Registry build 21.09.26
6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jilin (2), Liaoning (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KLE
Manufacturer City Province Registered as Device types
Liaoning Upcera Co., Ltd. Benxi Liaoning Contract manufacturer 10
Shenzhen Upcera Digital Dental Technology Co., Ltd. Shenzhen Guangdong Exporter 10
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7
CAO (China) Medical Equipment Company, Limited Langfang Hebei Contract manufacturer 6
Sincera Technology (Changchun) Co., Ltd. Changchun Jilin Manufacturer 2
Sino-Dentex Co., Ltd. Changchun Jilin Manufacturer 2

Record

Regulatory record for Interface Ceramic Etch and Silane
Listed by Vista Dental
FDA product code KLE
Device type Agent, Tooth Bonding, Resin
Device class Class 2
Regulation 21 CFR 872.3200
510(k) K053103
Record published 2016-06-16
Record revised 2021-02-04 (version 4)

Specifications

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

Catalogue Numbers

Catalogue numbers for Interface Ceramic Etch and Silane
Catalogue number Size Status
1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Epic® Parkell, Inc. 22
All-Bond Universal Bisco, Inc. 18
Henry Schein Henry Schein, Inc. 16
Peak Universal Bond Ultradent Products Inc. 16
Brush&Bond® Parkell, Inc. 16
All-Bond 2 Bisco, Inc. 15
The Orthodontic Store Young Innovations Inc. 15
All-Bond 3 Bisco, Inc. 13
Scotchbond™ Universal 3M Deutschland GmbH 13
Select HV Etch w/BAC Bisco, Inc. 12
Prelude Danville Materials, LLC 12
Jade Dharma Research, Inc. 12

Showing 12 of 609. All products under Agent, Tooth Bonding, Resin

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