Natural Profile Healing Abutment

GUDID 08415491016003

Devices are used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as com¬plete or partial dentures. Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for restoration.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491016003
• NIH Device Record Key: 8185f088-048e-4f90-a67c-ace71e8a5ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natural Profile Healing Abutment
• Version Model Number: 904253
• 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: true
• 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	08415491016003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892124

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-10

On-Brand Devices [Natural Profile Healing Abutment]

• 08415491043450: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
• 08415491039750: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
• 08415491016003: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
• 00841549111716: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
• 00841549110832: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
• 00841549110733: Devices are used in dental implant applications for oral rehabilitation of edentulous and partia