Pad Lock

Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Pad Lock® paste will fluoresce when illuminated with a black light to reveal flash upon bracket…

Registry build 21.09.26

Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Pad Lock® paste will fluoresce when illuminated with a black light to reveal flash upon bracket placement. In addition, the cured paste under the bracket base will fluoresce at the time of debonding making it easier to see and remove the adhesive. This is a Thin Viscosity Kit in Tip Dispensing. It contains (4) 4.5g Thin Paste in syringe tips, (2) 3cc Light Bond™ sealants, 9g Etching agent (liquid or gel), mixing pad, spatulas and brushes. This is a non-Fluoride Kit.

6manufacturers in China registered for this device type
7catalogue 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 Pad Lock
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
Record published 2016-08-10
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 refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temper ature prior to use.
Distribution end date 2019-05-09

Catalogue Numbers

Catalogue numbers for Pad Lock
Catalogue number Size Status
PLPKPLUS In distribution
PLTKFAS Withdrawn
PLPKFPLUS Withdrawn
PLTPK Withdrawn
PLTTK Withdrawn
PLPKAS Withdrawn
PLTKAS Withdrawn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