Border-Lock® Autoclavable Complete Tray Set - Dental impression tray, multi-use - CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Duns Number:626406016

Device Description: Dental impression tray, multi-use

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


More Product Details

Catalog Number

185800

Brand Name

Border-Lock® Autoclavable Complete Tray Set

Version/Model Number

185800

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

-

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

EHY

Product Code Name

TRAY, IMPRESSION, PREFORMED

Device Record Status

Public Device Record Key

cdcf1e3b-6bba-46fc-a7ba-3db5b9964133

Public Version Date

March 27, 2020

Public Version Number

1

DI Record Publish Date

March 19, 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