Stern Root Anchor® Mini X-Oversized Grey Males, 5

Basic Information

• Brand Name: Stern Root Anchor® Mini X-Oversized Grey Males, 5
• Primary DI: 00841549106927
• Version / Model: 833251
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-16
• Public Version: 7
• Public Version Date: 2023-03-24
• Public Version Status: Update
• Public Device Record Key: 7b7ca24f-8b31-436e-a72e-df4ead41965a

Device Description

Stern Root Anchor® Extra oversized males for mini female, grey w/ white collar, 5. The approximate diameter of the ball area of the Stern Root Anchor® males is as follows: White 1.7mm, Orange 1.8mm, Gray 1.9mm. The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth.

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: No
• 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
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

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	00841549106927	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K950213	000