Constic A1 - Self-adhesive, light-curing, flowable composite. - DMG Chemisch-Pharmazeutische Fabrik GmbH

Duns Number:320744915

Device Description: Self-adhesive, light-curing, flowable composite. Do more with less. Content: 2 syringes @ Self-adhesive, light-curing, flowable composite. Do more with less. Content: 2 syringes @ 2g composite, accessories. Color: A1.

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More Product Details

Catalog Number

220700

Brand Name

Constic A1

Version/Model Number

220700

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

K102603,K102603

Product Code Details

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Device Record Status

Public Device Record Key

f97b6d5e-5fc9-436f-84c7-63dfd60c9023

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

EDMG2207001

Quantity per Package

2

Contains DI Package

EDMG2207000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 143