TRU NP Healing Abutment 5mm, Ti

GUDID 08415491153098

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 the restorative phase. It is made out of 6AL-4V ELI Titanium Alloy, ASTM F136-12a. Device is supplied as a narrow platform with a 5mm cuff.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491153098
• NIH Device Record Key: 134fa369-6cf5-44a0-9c7d-85925715cb2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRU NP Healing Abutment 5mm, Ti
• Version Model Number: 901388
• 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	08415491153098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150968

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2015-10-21

On-Brand Devices [TRU NP Healing Abutment 5mm, Ti]

• 08415491153098: Healing Abutments are intended for placement onto the implant during stage II surgery. As the ti
• 00841549107689: Healing Abutments are intended for placement onto the implant during stage II surgery. As the ti