AccessGUDID - DEVICE: Tru-Paque (D8370720610)

GUDID

Device Identifier (DI) Information

Brand Name: Tru-Paque
Version or Model: Pink Blend - 50 mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07-2061
Company Name: Taub Products

Primary DI Number: D8370720610
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: Masks out metal partial framework, veneers, copings & bridgework. 5 - 7 micron film thickness. Air dries in 15 seconds. Does not affect undercuts. Opaques Monomer/powder acrylic systems. Use all colors (except Pink) on Labial / buccal metal surface prior to placement of acrylic or other resin.

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:	Yes
Prescription Use (Rx):	No
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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: Keep away from open flame. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: 3e10482a-92b0-45b8-9b40-e5950a2c9a61
Public Version Date: July 04, 2023
Public Version Number: 1
DI Record Publish Date: June 26, 2023