NC/RC Screw, for screw-retained abutment,straight 0°, GH2.5mm - BIO CONCEPT CO.,LTD

Duns Number:527603266

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More Product Details

Catalog Number

-

Brand Name

NC/RC Screw, for screw-retained abutment,straight 0°, GH2.5mm

Version/Model Number

141030

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"

-

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

K212364

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

6f7c2d71-d045-4f73-a163-180a11e72ba2

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO CONCEPT CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1021