Cleared Traditional

K000834 - CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO (FDA 510(k) Clearance)

Class I Dental device.

K000834 · Castellini S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
275d
Days
Class 1
Risk

K000834 is an FDA 510(k) clearance for the CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS:.... Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Castellini S.P.A. (Castel Maggiore, Bologna, IT). The FDA issued a Cleared decision on December 14, 2000 after a review of 275 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Castellini S.P.A. devices

Submission Details

510(k) Number K000834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date December 14, 2000
Days to Decision 275 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 127d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 260
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K000834.
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
K251388 · Foshan Topmed Dental Co., Ltd. · Jan 2026
High speed air turbine handpiece
K251389 · Foshan Topmed Dental Co., Ltd. · Jan 2026
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · W&H Dentalwerk B?rmoos GmbH · Feb 2025
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
K240337 · Guangdong Jinme Medical Technology Co., Ltd. · Nov 2024
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)
K241074 · Foshan Soco Precision Instrument Co., Ltd. · Nov 2024
Air Powered Tooth Polishing System (Perio-Mate)
K241880 · Nakanishi, Inc. · Sep 2024