Catalog Number

B-3605

Brand Name

Ace All-Bond TE Cartrdg(Pouch)

Version/Model Number

B-3605

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 05, 2019

Issuing Agency

In HIBCC

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

K102844

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Public Device Record Key

85eca9bd-9ce9-48f6-bff2-fc2f4b8290f2

Public Version Date

March 06, 2019

Public Version Number

4

DI Record Publish Date

June 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-