Restore - Surgical Kit - KEYSTONE DENTAL, INC.

Duns Number:787471015

Device Description: Surgical Kit

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More Product Details

Catalog Number

-

Brand Name

Restore

Version/Model Number

L9102-1K

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

OFY

Product Code Name

Dental implant surgical tray

Device Record Status

Public Device Record Key

f76ecf2a-2b2e-4ebb-8196-22c6bf79de2f

Public Version Date

March 25, 2021

Public Version Number

2

DI Record Publish Date

May 24, 2019

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