Universal Precision Composite Instrument #6 (UPC6) - Dental restorative material applicator - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Dental restorative material applicator

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More Product Details

Catalog Number

062116

Brand Name

Universal Precision Composite Instrument #6 (UPC6)

Version/Model Number

062116

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2022

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)

-

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Device Record Status

Public Device Record Key

1c41f692-f900-4e8c-888e-53f43e48eec2

Public Version Date

November 01, 2022

Public Version Number

2

DI Record Publish Date

March 17, 2020

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