OCT - Angled Abutment - KEYSTONE DENTAL, INC.

Duns Number:787471015

Device Description: Angled Abutment

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More Product Details

Catalog Number

SYN20D-C6

Brand Name

OCT

Version/Model Number

SYN20D-C6

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 26, 2019

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"

Yes

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

-

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

b257f151-fc49-42d2-9402-171c724bc8a6

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

February 11, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEYSTONE DENTAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 476
2 A medical device with a moderate to high risk that requires special controls. 1336