OKTAGON BL RC Burn-out plastic coping for crown, Ø 5.0 mm - BL RC Burn-out plastic coping for crown, Ø 5.0 mm - Hager & Meisinger Gesellschaft mit beschränkter Haftung

Duns Number:318034329

Device Description: BL RC Burn-out plastic coping for crown, Ø 5.0 mm for OKTAGON Dental Implant BL RC

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More Product Details

Catalog Number

22117

Brand Name

OKTAGON BL RC Burn-out plastic coping for crown, Ø 5.0 mm

Version/Model Number

22117

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

b3cd9fd2-3fa9-4422-84a1-9d3ba40c86ef

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

August 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HAGER & MEISINGER GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4140
2 A medical device with a moderate to high risk that requires special controls. 237