Biotem - Biotem BR ANGLED ABUTMENT 5.0mm Ⅹ 2mm(cuff) - Biotem Co., ltd

Duns Number:557793214

Device Description: Biotem BR ANGLED ABUTMENT 5.0mm Ⅹ 2mm(cuff) Ⅹ15'(angle)

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More Product Details

Catalog Number

-

Brand Name

Biotem

Version/Model Number

AABT50215

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

849a1da7-1cad-4d51-859b-9a3cd7d269d7

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

June 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTEM CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 164
2 A medical device with a moderate to high risk that requires special controls. 378