Stern Snap One Piece Abutment 4mm Cuff (BF) - The SternSnap Attachment is indicated for use - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: The SternSnap Attachment is indicated for use with dental implants to support and/or retai The SternSnap Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants. The SternSnap Attachment consists of a modified ball, which screws into an SFI Abutment and a retaining cap that gets processed into the denture. The retaining female engages the outside of the ball shape and allows retention of the prosthesis to the denture.

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More Product Details

Catalog Number

-

Brand Name

Stern Snap One Piece Abutment 4mm Cuff (BF)

Version/Model Number

904805

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

41728f55-2e62-44db-a2d9-76b5afc3f89c

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