Temp Esthetic - Temp Esthetic Disc, 95 X 20mm, Shade C1 - Harvest Dental Products, LLC

Duns Number:794668751

Device Description: Temp Esthetic Disc, 95 X 20mm, Shade C1

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More Product Details

Catalog Number

-

Brand Name

Temp Esthetic

Version/Model Number

30071-20

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

Yes

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

K102341

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

12673620-d54f-4284-abde-693d3296c1bd

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARVEST DENTAL PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 94