Accu Light Temporary Restorative, Single Syringe - • Easy to apply; fast cure.• Outstanding depth of - DENT ZAR, INC.

Duns Number:789664455

Device Description: • Easy to apply; fast cure.• Outstanding depth of cure.• Reliable performance.• Good mecha

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More Product Details

Catalog Number

0057

Brand Name

Accu Light Temporary Restorative, Single Syringe

Version/Model Number

0057

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

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

fec38d82-5a3b-4ea6-b60a-8c5dfa46ca88

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENT ZAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 59