AccessGUDID - DEVICE: SternSnap Angled Attachment (00841549110382)

GUDID

Device Identifier (DI) Information

Brand Name: SternSnap Angled Attachment
Version or Model: 904123
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STERNGOLD DENTAL LLC

Primary DI Number: 00841549110382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124763728 *Terms of Use

Device Description: Introducing the new Stern SNAP Angled Overdenture Implant Abutment System, compatible with all popular implant systems. Its Innovative Two-piece design allows the SNAP Angled to perform True Angle Correction of up 20 degrees on divergent implants, without the need to rely on a hinging attachment. The System features a New Maximum Durability Cap, (available in 1lb, 2lb, and 3lb,) that does not require a housing, making for a low profile of only 2.5mm and requiring less space needed in the denture. The Stern SNAP is an Innovative, Predictable, and Economical solution for stabilizing your patients’ denture.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38603	Resilient dental precision attachment	A dental fixation device designed to give a tooth-borne/tissue-borne prosthesis sufficient mechanical play to withstand the variations in the seating of the prosthesis due to deformation of the underlying tissues, without placing excessive stress on the abutments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150250	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8fab80d-3314-462d-b2ff-0a6534d3e0fe
Public Version Date: March 24, 2023
Public Version Number: 7
DI Record Publish Date: May 23, 2017