Home GUDID D9439019ELUL0 Power Dental USA
Primary DI D9439019ELUL0
Brand Power Dental USA
Company Power Dental U.S.A. Inc.
Model 9019-ELUL
Catalog number 9019-ELUL
Device description LUXATOR LARGE HANDLE SET (8 PCS)
Published 2021-07-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name MDM INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D9439019ELUL0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Ultrasonic dental scaling/debridement system handpiece tip, periodontal An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. 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 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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