Harvard PremiumSil Mono Fast - Vinylpolysiloxane impression material, super - Harvard Dental International GmbH

Duns Number:341553293

Device Description: Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2

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More Product Details

Catalog Number

-

Brand Name

Harvard PremiumSil Mono Fast

Version/Model Number

7083722

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

-

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

K012767,K012767

Product Code Details

Product Code

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

5c5b2227-85ea-4eef-967b-a24bc6297669

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARVARD DENTAL INTERNATIONAL GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 131