Home GUDID D990SF1PKOA0 Separable Fastener 1PK, Omnibut
Primary DI D990SF1PKOA0
Brand Separable Fastener 1PK, Omnibut
Company SMART DENTURE CONVERSIONS, LLC
Model SF1PK-OA
Published 2025-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D990SF1PKOA0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 010613514 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D990SADCK1PK0 Single Arch Dam Conversion Kit 1PK SADCK1PK 2025-06-30 D990AD0 Access Drill 1PK AD 2022-12-26 D990BHHDPS10PK0 Prosthetic Screw 10PK, BioHorizons BHHD-PS10PK 2022-12-26 D990BHHDPSK0 Premium Starter Kit, BioHorizons BHHD-PSK 2022-12-26 D990BHHDRK0 Recharge Kit, BioHorizons BHHD-RK 2022-12-26 D990BHHDSFA10PKDK0 Separable Fastener Assembly 10PK w Drill Kit, BioHorizons BHHD-SFA10PKDK 2022-12-26 D990BHHDSK0 Starter Kit, BioHorizons BHHD-SK 2022-12-26 D990CM10PK0 Coating Mandrel 10PK CM10PK 2022-12-26 D990CM6PK0 Coating Mandrel 6PK CM6PK 2022-12-26 D990COD0 Clean Out Drill 1PK COD 2022-12-26 D990DK0 Drill Kit 1PK DK 2022-12-26 D990KDIHCM10PK0 Coating Mandrel 10 Pack, Paltop (IHEX) KDIH-CM10PK 2022-12-26 D990KDIHCM6PK0 Coating Mandrel 6PK, Paltop (IHex) KDIH-CM6PK 2022-12-26 D990KDIHLA10PK0 Lab Analog 10PK, Paltop (IHex) KDIH-LA10PK 2022-12-26 D990KDIHLTD0 Torque Driver 1PK, Paltop (IHex) KDIH-LTD 2022-12-26 D990KDIHPS10PK0 Prosthetic Screw 10PK, Paltop (IHex) KDIH-PS10PK 2022-12-26 D990KDIHPSK0 Premium Starter Kit, Paltop (IHex) KDIH-PSK 2022-12-26 D990KDIHRK0 Recharge Kit, Paltop (IHex) KDIH-RK 2022-12-26 D990KDIHSFA10PKDK0 Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex) KDIH-SFA10PKDK 2022-12-26 D990KDIHSK0 Starter Kit, Paltop (IHex) KDIH-SK 2022-12-26
Other Devices Sharing Product Codes# 
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