Porcelain Etch - Viscous 9.5% Hydrofluoric Acid Solution. For - Vista Dental

Duns Number:036623932

Device Description: Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementa Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementation or repairs. Refill kit includes (2) 1.2mL prefilled etch syringes, (25) Spira-Flo™ brush tips

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More Product Details

Catalog Number

-

Brand Name

Porcelain Etch

Version/Model Number

502512

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K933766,K933766

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

8d9c39d7-078c-4354-89a8-1ac74bb5f031

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISTA DENTAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 316
2 A medical device with a moderate to high risk that requires special controls. 144
U Unclassified 36