Cleared Traditional

PROPHYLAXIS ANGLE

K780752 · Young Dental Manufacturing Co. 1, LLC · Dental
May 1978
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K780752 is an FDA 510(k) clearance for the PROPHYLAXIS ANGLE, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978, 18 days after receiving the submission on May 8, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K780752 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1978
Decision Date May 26, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

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