Home GUDID D943N81215 Power Dental U.S.A., Inc.
Primary DI D943N81215
Brand Power Dental U.S.A., Inc.
Company Power Dental U.S.A. Inc.
Model N8121-5
Catalog number N8121-5
Device description PIEZO BONE SURGERY TIPS FOR SURGIMASTER AND SURGIMASTER II,DCA10 Crestal approach tip 10mm with internal irrigation
Published 2021-07-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 D943N81215 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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false 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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