BondLink - BONDLINK KIT - DEN-MAT HOLDINGS, LLC

Duns Number:809857704

Device Description: BONDLINK KIT

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More Product Details

Catalog Number

031148100

Brand Name

BondLink

Version/Model Number

031148100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K801216

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

440dfc8f-be51-43a0-adfd-2616733fb421

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEN-MAT HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 278