RP One-Piece Standard Abutment 4.0mm Cuff

Basic Information

• Brand Name: RP One-Piece Standard Abutment 4.0mm Cuff
• Primary DI: 00841549107061
• Version / Model: 901103
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-30
• Public Version: 7
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 0f1d87d5-3224-4a84-aa85-10cbb74f4df1
• Distribution End Date: 2023-10-06

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549107061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K892124	000