AccessGUDID - DEVICE: Pure PMMA Disc (04806532671062)

GUDID

Device Identifier (DI) Information

Brand Name: Pure PMMA Disc
Version or Model: Shade: B3, Thickness: 18mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 106
Company Name: QUEST DENTAL MATERIAL CORPORATION

Primary DI Number: 04806532671062
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 721541530 *Terms of Use

Device Description: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172281	000

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: Room temperature, avoid direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 98 Millimeter
Device Size Text, specify: Thickness: 18mm

Device Record Status

Public Device Record Key: ad3f10c5-bf47-4642-9c90-8ed921afd5e2
Public Version Date: October 29, 2021
Public Version Number: 4
DI Record Publish Date: December 20, 2017