Home GUDID D990PTB1PK0 Pre-Coated TiBase 1PK
Primary DI D990PTB1PK0
Brand Pre-Coated TiBase 1PK
Company SMART DENTURE CONVERSIONS, LLC
Model PTB1PK
Published 2025-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Single use true Product Codes# Code, Name table Code Name EJX Anchor, Preformed NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EJX Anchor, Preformed Dental 1 NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D990PTB1PK0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, temporary, preformed, single-use A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.
Regulatory Flags# DUNS number 010613514 Device count 1 Premarket exempt true Lot or batch 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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