Stern IC/AC RN Cover Screw, Type .048 Hex

GUDID 08415491062079

Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491062079
• NIH Device Record Key: 01bd6b7e-bc0c-4600-a0ca-ffd43cdc2a9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stern IC/AC RN Cover Screw, Type .048 Hex
• Version Model Number: 901090
• 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	08415491062079 [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 Cover Screw, Type .048 Hex]

• 08415491062079: Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off th
• 00841549106989: Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off th