SCOTT'S VPS PUTTY 2-JARS FAST SET MINT - Hydroclone VPS addition cured silicone - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exce Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association Specification No. 19. Products are available in multiple viscosities (and as a putty) in both tubes and cartridges for use in various impression techniques. Hydroclone VPS is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. During hot weather this material can be refrigerated to prevent degradation – but should be warmed to room temperature before use. Delivery method: two part putty, fast set, mint flavor.

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More Product Details

Catalog Number

104-8021

Brand Name

SCOTT'S VPS PUTTY 2-JARS FAST SET MINT

Version/Model Number

104-8021

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

-

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

521138ac-9a01-4b42-926f-ebee3bd2028f

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

June 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTT'S DENTAL SUPPLY L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1050
2 A medical device with a moderate to high risk that requires special controls. 90