Home GUDID D894R4350 PiezoImplant System
Primary DI D894R4350
Brand PiezoImplant System
Company Rex Implants, Inc.
Model MUA Temporary Coping BL 2.9
Catalog number R4-35
Published 2022-12-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
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 D894R4350 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 4.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080746478 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D894B2094C0 PiezoImplant System REX BL 2.9 x 4 H9 B2-094C 2022-12-24 D894B2095C0 PiezoImplant System REX BL 2.9 x 5 H9 B2-095C 2022-12-24 D894B2114C0 PiezoImplant System REX BL 2.9 x 4 H11 B2-114C 2022-12-24 D894B2115C0 PiezoImplant System REX BL 2.9 x 5 H11 B2-115C 2022-12-24 D894B2134C0 PiezoImplant System REX BL 2.9 x 4 H13 B2-134C 2022-12-24 D894B2135C0 PiezoImplant System REX BL 2.9 x 5 H13 B2-135C 2022-12-24 D894B2154C0 PiezoImplant System REX BL 2.9 x 4 H15 B2-154C 2022-12-24 D894B2155C0 PiezoImplant System REX BL 2.9 x 5 H15 B2-155C 2022-12-24 D894R4040 PiezoImplant System Retention Screw BL 2.9 R4-04 2022-12-30 D894R4050 PiezoImplant System Straight Abutment BL 2.9 H1 R4-05 2022-12-30 D894R4060 PiezoImplant System Straight Abutment BL 2.9 H2 R4-06 2022-12-30 D894R4070 PiezoImplant System Straight Abutment BL 2.9 H3 R4-07 2022-12-30 D894R4080 PiezoImplant System Cover Screw BL 2.9 R4-08 2022-12-30 D894R4090 PiezoImplant System Impression Pin L BL 2.9 R4-09 2022-12-30 D894R4100 PiezoImplant System Impression Pin S BL 2.9 R4-10 2022-12-30 D894R4120 PiezoImplant System Lab Analog BL 2.9 R4-12 2022-12-30 D894R4130 PiezoImplant System Healing Abutment BL 2.9 H1 R4-13 2022-12-30 D894R4140 PiezoImplant System Healing Abutment BL 2.9 H2 R4-14 2022-12-30 D894R4150 PiezoImplant System Healing Abutment BL 2.9 H3 R4-15 2022-12-30 D894R4160 PiezoImplant System Healing Abutment BL 2.9 H4 R4-16 2022-12-30
Other Devices Sharing Product Codes# 
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