Home GUDID D943N1221 Power Dental U.S.A., Inc.
Primary DI D943N1221
Brand Power Dental U.S.A., Inc.
Company Power Dental U.S.A. Inc.
Model N1221
Catalog number N1221
Device description SCALERS POSTERIOR N129
Published 2021-06-20
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 EMN SCALER, PERIODONTIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMN Scaler, Periodontic Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D943N1221 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Manual dental scaler, reusable A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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 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 D9431007E0 Power Dental USA 1007E 1007E 2021-07-13 D94315240 Power Dental USA 1524 1524 2021-06-20 D94335090 Power Dental USA 3509 3509 2021-06-20 D9434826XAS0 Power Dental USA 4826XAS 4826XAS 2021-07-13 D94362100 Power Dental USA 6210 6210 2021-06-20 D94364470 Power Dental USA 6447 6447 2022-01-08 D943813050 Power Dental USA 8130-5 8130-5 2021-07-13 D943DCAM0 Power Dental USA DCAM DCAM 2021-07-13 D943DCAM30 Power Dental USA DCAM3 DCAM3 2021-07-13 D943KIM10 Power Dental USA KIM-1 KIM-1 2022-07-12 D943KIM120 Power Dental USA KIM-12 KIM-12 2022-07-12 D943KIM20 Power Dental USA KIM-2 KIM-2 2022-07-12 D943KIM240 Power Dental USA KIM-24 KIM-24 2021-07-13 D943KIM30 Power Dental USA KIM-3 KIM-3 2022-07-12
Other Devices Sharing Product Codes# 
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