Home GUDID 00850073333822 AOX 3DDX Kit
Primary DI 00850073333822
Brand AOX 3DDX Kit
Company 3D DIAGNOSTIX, INC.
Model Dental implant suprastructure, temporary, preforme
Device description 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.
Published 2026-09-22
Public version status New
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
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 00850073333822 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850073333822 00850073333822 850073333822 0850073333822
GMDN Terms# Term, Definition table Term Definition Dental implant suprastructure, temporary, preformed, reusable 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004512027 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850073333563 3DDX Straight Drill Kit Dental/maxillofacial surgical procedure kit, non-m 2025-09-10 00850073333013 Night Guard Printed Night Guard 2025-09-11 00850073333136 Straight Drill LSD 02.75x15 - Black Dental drill bit, reusable / Straight Drill LSD 02 2025-09-11 00850073333143 Straight Drill LSD 02.75x18 - White Dental drill bit, reusable / Straight Drill LSD 02 2025-09-11 00850073333150 Straight Drill LSD 02.75x20 - Blue Dental drill bit, reusable / Straight Drill LSD 02 2025-09-11 00850073333167 Straight Drill LSD 02.75x23 - Green Dental drill bit, reusable / Straight Drill LSD 02 2025-09-11 00850073333174 Straight Drill LSD 02.75x25 - Yellow Dental drill bit, reusable / Straight Drill LSD 02 2025-09-11 00850073333198 Straight Drill LSD 03.15x15 - Black Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333204 Straight Drill LSD 03.15x18 - White Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333211 Straight Drill LSD 03.15x20 - Blue Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333228 Straight Drill LSD 03.15x23 - Green Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333235 Straight Drill LSD 03.15x25 - Yellow Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333242 Straight Drill LSD 03.15x28 - Red Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333259 Straight Drill LSD 03.45x15 - Black Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333266 Straight Drill LSD 03.45x18 - White Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333273 Straight Drill LSD 03.45x20 - Blue Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333280 Straight Drill LSD 03.45x23 - Green Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333297 Straight Drill LSD 03.45x25 - Yellow Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333303 Straight Drill LSD 03.45x28 - Red Dental drill bit, reusable / Straight Drill LSD 03 2025-09-11 00850073333310 Straight Drill LSD 04.20x14 - Black Dental drill bit, reusable / Straight Drill LSD 04 2025-09-11
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