Home GUDID D943N4033N00 Power Dental U.S.A., Inc.
Primary DI D943N4033N00
Brand Power Dental U.S.A., Inc.
Company Power Dental U.S.A. Inc.
Model N4033N
Catalog number N4033N
Device description """POWER FLEX"" POWER FLEX TWIST PERIOTOME / ELEVATOR 3.7mm WIDTH ± 5 % SET OF 3 ..Patent No. USD700331S USD700329SX TWIST PERIOTOME / ELEVATOR 3.7mm WIDTH ± 5 % SET OF 3 ..Patent No. USD700331S USD700329S"
Published 2021-07-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name EMJ ELEVATOR, SURGICAL, DENTAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMJ Elevator, Surgical, Dental Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D943N4033N00 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Periotome, reusable A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081305064 Device count 1 Premarket exempt true Kit true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D94320240 Power Dental USA 2024 2024 2021-06-20 D94341260 Power Dental USA 4126 4126 2021-06-20 D943ORCAA0 Power Dental USA ORCAA ORCAA 2021-06-20 D94367350 Power Dental USA 6735 6735 2021-06-20 D94367380 Power Dental USA 6738 6738 2021-06-20 D94367390 Power Dental USA 6739 6739 2021-06-20 D94367410 Power Dental USA 6741 6741 2021-06-20 D94367430 Power Dental USA 6743 6743 2021-06-20 D94367140 Power Dental USA 6714 6714 2021-06-20 D94367420 Power Dental USA 6742 6742 2021-06-20 D9436710E0 Power Dental USA 6710E 6710E 2021-07-13 D94367310 Power Dental USA 6731 6731 2021-06-20 D94367320 Power Dental USA 6732 6732 2021-06-20 D94367150 Power Dental USA 6715 6715 2021-06-20 D9436716 Power Dental USA 6716 6716 2021-06-20 D9436733 Power Dental USA 6733 6733 2021-06-20 D9436734 Power Dental USA 6734 6734 2021-06-20 D9436740 Power Dental USA 6740 6740 2021-06-20 D9436750 Power Dental USA 6750 6750 2022-01-08 D9431007E0 Power Dental USA 1007E 1007E 2021-07-13
Other Devices Sharing Product Codes# 
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