Pure PMMA Disc - Pure PMMA Discs are polymenthyl methacrylate - QUEST DENTAL MATERIAL CORPORATION

Duns Number:721541530

Device Description: Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporar 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.

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More Product Details

Catalog Number

468

Brand Name

Pure PMMA Disc

Version/Model Number

Shade: MLC4, Thickness: 20mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172281

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

184757a3-51a3-44a1-8056-3f748547fad7

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUEST DENTAL MATERIAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 511