Cleared Traditional

Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray

K150750 · Sirona Dental Systems GmbH · Dental
Jul 2015
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K150750 is an FDA 510(k) clearance for the Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on July 2, 2015, 101 days after receiving the submission on March 23, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K150750 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2015
Decision Date July 02, 2015
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

Similar Devices — EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 72
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · Premium Plus (Dongguan) Limited · Sep 2025
Disposable Prophy Angle
K240950 · Pacific Care Limited · May 2025
Star E900 Handpiece Series
K240183 · Dentalez, Inc., Stardental Division · Sep 2024
General Cutting Straight
K230106 · Nakanishi, Inc. · May 2023
FX Contra
K222518 · Nakanishi, Inc. · Nov 2022
Lotus Prophy Angle
K220346 · Ajk Engineering, Inc. · Nov 2022