SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY - Big-Bite Bite Registration material is a unique - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: Big-Bite Bite Registration material is a unique mousse-like, radiopaque impression materia Big-Bite Bite Registration material is a unique mousse-like, radiopaque impression material that was designed for registering bite relationships between upper and lower jaws. The thixotropic properties of this material allow for easy flow without slumping. The material’s high durometer helps ensure accurate model articulation. Big-Bite Bite Registration material is compatible with gypsum or epoxy die materials and can be copper or silver plated.Big-Bite Bite Registration material 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. Delivery Method: Dispensing Cartridge, fast set, berry flavor.SDS and instructions for use available at https://www.scottsdental.com/big-bite-registration-hp.html

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More Product Details

Catalog Number

104-7110

Brand Name

SCOTT'S BIG-BITE HP 2/bx FAST SET BERRY

Version/Model Number

104-7110

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

a50804a6-91e3-4eaa-9777-c94bbc8fb34a

Public Version Date

August 26, 2020

Public Version Number

3

DI Record Publish Date

October 25, 2018

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