DiamoDent - CEMENT-ON POST, Titanium2mm Collar, 4.4mm - DIAMODENT INC

Duns Number:013827410

Device Description: CEMENT-ON POST, Titanium2mm Collar, 4.4mm Profile3.4mm, BIOMET 3i, Certain Implants

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More Product Details

Catalog Number

AJ510

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

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

98aec32b-8e6b-46a5-89f5-893a4a43c50c

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

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