MPa Universal™ Light-Cure Universal Adhesive Unit Dose 50PK - Dentine bonding agent/set - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Dentine bonding agent/set

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

267000

Brand Name

MPa Universal™ Light-Cure Universal Adhesive Unit Dose 50PK

Version/Model Number

267000

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

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

-

Product Code Details

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Device Record Status

Public Device Record Key

b7061abd-827e-4ff5-a6cb-3b638b44875a

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINICIAN'S CHOICE DENTAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1461
2 A medical device with a moderate to high risk that requires special controls. 234
U Unclassified 6