Pad Lock

Basic Information

• Brand Name: Pad Lock
• Primary DI: D798PLTPK0
• Version / Model: PLTPK
• Catalog Number: PLTPK
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Labeler DUNS: 113170088
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-03
• Public Version: 3
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: e95cac33-0c73-489b-9a70-1f1abce2a0e8
• Distribution End Date: 2017-12-21

Device Description

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 Thin Viscosity Push Syringe kit contains: (4) 4.5g Thin Paste in push syringes, (2) 3cc Light Bond™ sealants, 9g Liquid Etching agent, mixing pad, spatulas and brushes. This is a Non-Fluoride Kit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	No	Active
36153	Dental tooth-etching solution	An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D798PLTPK0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at refrigerated conditions (2-8 Degrees C)