Stern Snap One Piece Abutment 3mm Cuff (A) - SternSnap Overdenture Implant Abutment System - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: SternSnap Overdenture Implant Abutment System that can be used to retain overdentures on m SternSnap Overdenture Implant Abutment System that can be used to retain overdentures on most popular implants. It features a low profile that takes up only 2.5mm of height in the denture and has a long-lasting plastic retention cap that comes in three retention levels (1 lb, 2lb and 3 lb) and doesn’t require a metal housing, making it a simpler, more economical option. Contents: 1 attachment, 1 each Yellow and Green retaining caps, 1 blockout spacer.

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More Product Details

Catalog Number

-

Brand Name

Stern Snap One Piece Abutment 3mm Cuff (A)

Version/Model Number

904614

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

K142407

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

c157489e-38f2-49eb-b4d3-c54d5da76888

Public Version Date

January 08, 2020

Public Version Number

6

DI Record Publish Date

May 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERNGOLD DENTAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 1346