Separable Fastener Reference Base 10PK, Extended Thread

Basic Information

• Brand Name: Separable Fastener Reference Base 10PK, Extended Thread
• Primary DI: D990SFRB10PKEX0
• Version / Model: SFRB10PK-EX
• Company Name: SMART DENTURE CONVERSIONS, LLC
• Labeler DUNS: 010613514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-01
• Public Version: 2
• Public Version Date: 2025-06-11
• Public Version Status: Update
• Public Device Record Key: 2e4f19cb-a6ed-480f-9a7b-909966195297

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64312	Dental prosthesis/implant abutment screw analog, single-use	A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Some types are referred to as a guide pin, and may be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D990SFRB10PKEX0	HIBCC

Customer Contacts

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