Stern Latch® Male

Basic Information

• Brand Name: Stern Latch® Male
• Primary DI: 00841549100604
• Version / Model: 802012
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-02
• Public Version: 2
• Public Version Date: 2021-01-21
• Public Version Status: Update
• Public Device Record Key: 0883c97a-49d4-4722-9036-8e08463c6983
• Distribution End Date: 2021-01-20

Device Description

Rigid attachments are highly stable connectors with very slight movements in function. When abutment teeth are stable, rigid attachments are often the connectors of choice. Some can be used for segmenting fixed partial dentures to simplify future case conversion to a removable restoration.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549100604	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]