AccessGUDID - DEVICE: Pad Lock (D798PLTKFAS0)

GUDID

Device Identifier (DI) Information

Brand Name: Pad Lock
Version or Model: PLTKFAS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PLTKFAS
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798PLTKFAS0
Issuing Agency: HIBCC
Commercial Distribution End Date: December 21, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

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. Kit contains 18g adhesive paste in Dispensing Tips, 1 X 6cc Assure Bonding resin, 9 gm liquid etchant, mixing pad, spatulas and brush applicators. This kit contains Fluoride.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	Agent, Tooth Bonding, Resin
DYH	Adhesive, Bracket And Tooth Conditioner, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temper ature prior to use.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a7e967a-66e3-47af-ae5e-3c14833b35cd
Public Version Date: February 16, 2024
Public Version Number: 3
DI Record Publish Date: August 10, 2016