Diamodent - Compatible with: 3.75 Regular Platform (RP) - DIAMODENT INC

Duns Number:013827410

Device Description: Compatible with: 3.75 Regular Platform (RP) Branemark implantsUCLA Abutment, Gold/Clear Pl Compatible with: 3.75 Regular Platform (RP) Branemark implantsUCLA Abutment, Gold/Clear PlasticNon-Hexed, 0.8mm Collar, 4.5mm Profile, Titefit

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More Product Details

Catalog Number

A101

Brand Name

Diamodent

Version/Model Number

N/A

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

-

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

90697a9b-a0bd-41f5-9055-91a5ceb900f0

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

January 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMODENT INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 78
2 A medical device with a moderate to high risk that requires special controls. 283