AMALGAMBOND® - ‘HPA’ Powder AMALGAMBOND® - PARKELL, INC.

Duns Number:009900424

Device Description: ‘HPA’ Powder AMALGAMBOND®

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More Product Details

Catalog Number

S376

Brand Name

AMALGAMBOND®

Version/Model Number

S376

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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

-

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

e7f1f04d-8df0-4591-825c-8b5ea34f156f

Public Version Date

April 01, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19