Health-Tec MicroHybrid Composite - Health-Tec MicroHybrid Composite Shade A3 Unit - Dental Health Products Inc

Duns Number:623191194

Device Description: Health-Tec MicroHybrid Composite Shade A3 Unit Dose

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More Product Details

Catalog Number

210-HT20A3

Brand Name

Health-Tec MicroHybrid Composite

Version/Model Number

210-HT20A3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2022

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

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

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

88bf1644-b5fd-4e76-8646-29e6040b1d66

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENTAL HEALTH PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 464
2 A medical device with a moderate to high risk that requires special controls. 78