Hahn - Hahn Tapered Implant GL Titanium Abutment 6 mmH - - James R. Glidewell, Dental Ceramics, Inc.

Duns Number:021228671

Device Description: Hahn Tapered Implant GL Titanium Abutment 6 mmH - Ø7.0 Implant

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More Product Details

Catalog Number

70-1153-PRA0127

Brand Name

Hahn

Version/Model Number

70-1153-PRA0127

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

K143353

Product Code Details

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Device Record Status

Public Device Record Key

170bd566-83d0-4350-940a-c2bdbe3d6197

Public Version Date

June 17, 2021

Public Version Number

1

DI Record Publish Date

June 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JAMES R. GLIDEWELL, DENTAL CERAMICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 510
2 A medical device with a moderate to high risk that requires special controls. 2971
U Unclassified 2