OKTAGON Dental Implant BLT NC - Bone Level Tapered Implant Narrow Connect Ø3.3 x - Hager & Meisinger Gesellschaft mit beschränkter Haftung

Duns Number:318034329

Device Description: Bone Level Tapered Implant Narrow Connect Ø3.3 x 10mm

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More Product Details

Catalog Number

23002

Brand Name

OKTAGON Dental Implant BLT NC

Version/Model Number

23002

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

b2f6b873-d437-4921-8194-ae803c2070c5

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

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