ALPHA-DENT® Cavity Varnish - ALPHA-DENT® Cavity Varnish is used to form a - DENTAL TECHNOLOGIES, INC.

Duns Number:148312838

Device Description: ALPHA-DENT® Cavity Varnish is used to form a barrier to protect exposed dentin and reduce ALPHA-DENT® Cavity Varnish is used to form a barrier to protect exposed dentin and reduce fluid leakage around the tooth restoration interface. Kit Contains: 1 x 14ml Varnish

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More Product Details

Catalog Number

407.0101.001

Brand Name

ALPHA-DENT® Cavity Varnish

Version/Model Number

407.0101.001

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

K955521

Product Code Details

Product Code

LBH

Product Code Name

Varnish, Cavity

Device Record Status

Public Device Record Key

6a9b0641-3ace-43a1-9a57-99be116b1a1c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 183