Light Bond

Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned.…

Registry build 21.09.26

Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. Light Bond™ will bond to any enamel, porcelain, composite or metal surface, when properly conditioned. This Light Bond Medium Viscosity Kit contains 44 x Light Bond Medium dispensing tips, 1 X Assure Plus Bonding Resin, 1 X 23 gm liquid etchant and mixing accessories. This product contains fluoride.

6manufacturers in China registered for this device type
5catalogue numbers in this listing
2510(k) clearances naming this product code

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 Light Bond
Listed by Reliance Orthodontic Products, Inc., United States
FDA product code KLE
Device type Agent, Tooth Bonding, Resin
Device class Class 2
Regulation 21 CFR 872.3200
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K895522
Record published 2016-08-15
Record revised 2024-02-16 (version 6)

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 Special storage condition: Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Distribution end date 2019-05-08

Catalogue Numbers

Catalogue numbers for Light Bond
Catalogue number Size Status
LBEPF W/PLUS In distribution
LBEMTF W/PLUS Withdrawn
LBETFAS Withdrawn
LBESF Withdrawn
LBEMTF Withdrawn

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K210945 2021-07-08
K071688 2007-09-07

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