DEVICE: Stern Snap One Piece Abutment 4mm Cuff (AE) (00841549113833)
Device Identifier (DI) Information
Stern Snap One Piece Abutment 4mm Cuff (AE)
904809
In Commercial Distribution
STERNGOLD DENTAL LLC
904809
In Commercial Distribution
STERNGOLD DENTAL LLC
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.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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44879 | Dental implant suprastructure, permanent, preformed |
A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.
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FDA Product Code
[?]Product Code | Product Code Name |
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NHA | Abutment, Implant, Dental, Endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K142407 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
2d58696b-289a-4f2a-979c-baebded2f16c
January 10, 2020
6
May 23, 2017
January 10, 2020
6
May 23, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
401-871-3489
maria.rao@sterngold.com
maria.rao@sterngold.com