Dental Device Guide
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Surgical devices · 21 CFR 872 Subpart E

Rotary Scaler

FDA device type “Scaler, Rotary”.

FDA codeELBClass221 CFR872.4840Pathway510(k)
Companies listing it
22 makers
Brands and models
4
510(k) clearances
60 in five years
FDA name
Scaler, Rotary
1979: 11983: 12001: 12011: 12012: 12017: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list ELB

2 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
GENOSS Co., Ltd.South KoreaMakerTN-0.8 · TN-1 · TN-1.3232025
Electro Medical Systems SAUnited StatesMakerMiniEndo III52002

510(k) clearances

Decided510(k)DeviceApplicant
11 Sep 2017K170596TN-BrushGENOSS Co., Ltd.
17 Sep 2012K121114TIGRAN PERIBRUSHTigran Technologies AB
12 Sep 2011K111724STRAUMANN TIBRUSHInstitut Straumann AG
22 Feb 2001K003640MINIENDO IIISybron Dental Specialties
9 May 1983K831037AIR BURBINE HANDPIECE-DENTAL SCALINGTaco Dental, Inc.
3 Jan 1979K782007ROTARY SCALERStar Dental Mfg. Co.

Official records: FDA product classification for ELB · 21 CFR 872.4840.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026