RP One-Piece Standard Abutment 5.5mm Cuff

GUDID 08415491043252

RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multi-implant prostheses. Abutments are available in one-piece and two-piece styles. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08415491043252
• NIH Device Record Key: f55e6a8b-7b73-46d4-829e-f49958f81988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RP One-Piece Standard Abutment 5.5mm Cuff
• Version Model Number: 901105
• 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	08415491043252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K892124

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08415491043252]

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: 2017-05-30

On-Brand Devices [RP One-Piece Standard Abutment 5.5mm Cuff]

• 08415491043252: RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link
• 00841549107078: RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link