BruxZir Shaded 16 PLUS - BruxZir Shaded 16 PLUS Milling Blank C4 GD 10mm Z - James R. Glidewell, Dental Ceramics, Inc.

Duns Number:021228671

Device Description: BruxZir Shaded 16 PLUS Milling Blank C4 GD 10mm Z

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More Product Details

Catalog Number

70-1185-BXP0207

Brand Name

BruxZir Shaded 16 PLUS

Version/Model Number

70-1185-BXP0207

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K130924

Product Code Details

Product Code

EIH

Product Code Name

POWDER, PORCELAIN

Device Record Status

Public Device Record Key

043e7aca-74a2-4eb3-8455-d0dede19df9e

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JAMES R. GLIDEWELL, DENTAL CERAMICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 510
2 A medical device with a moderate to high risk that requires special controls. 2971
U Unclassified 2