Stern IC/AC RN 2mm Healing Cap .048 Hex

GUDID 08415491062994

Healing Caps 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.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491062994
• NIH Device Record Key: b7903a35-597a-489f-992a-5ddce9a1777d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern IC/AC RN 2mm Healing Cap .048 Hex
• Version Model Number: 901096
• 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	08415491062994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111798

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: 2015-11-04

On-Brand Devices [Stern IC/AC RN 2mm Healing Cap .048 Hex]

• 08415491062994: Healing Caps are intended for placement onto the implant during stage II surgery. As the tissue
• 00841549107030: Healing Caps are intended for placement onto the implant during stage II surgery. As the tissue