Catalog Number

-

Brand Name

Sparkle™ Prophy Angle

Version/Model Number

TPASFC1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K973062,K973062,K973062

Product Code

EFA

Product Code Name

Handpiece, belt and/or gear driven, dental

Public Device Record Key

854ddeb1-8eb8-4923-82f8-27456eb71b0b

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

50732224002915

Quantity per Package

12

Contains DI Package

10732224002917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-