Premium Plus Prophy Air Motor— 510(k) K170261

Clearance details

Applicant

Premium Plus International Limited

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

2017-01-27

Decision date

2017-10-19

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Hong Kong, CN

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• K251389 — High speed air turbine handpiece2026-01-12
• K242179 — Synea Fusion Handpieces (Intensiv & Profin)2025-02-28
• K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)2024-11-13
• K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)2024-11-12

• K163447 — Premium Plus Disposable Barrier Sleeve2017-06-20
• K153514 — Premium Plus C01/C02 LED Curing Light2016-08-22
• K100854 — PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 33992010-12-09

Injury

133

Malfunction

562

Total

695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →