Stern Root Anchor® Female Replicas, 5

GUDID 08415491021298

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.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491021298
• NIH Device Record Key: 83de8019-fb1d-4253-916c-0d544abce162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern Root Anchor® Female Replicas, 5
• Version Model Number: 833160
• Company DUNS: 124763728
• Company Name: STERNGOLD DENTAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 401-871-3489
• Email: maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08415491021298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950213

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08415491021298]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-05-16

On-Brand Devices [Stern Root Anchor® Female Replicas, 5]

• 08415491021298: The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S
• 00841549106880: The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S