Cleared Traditional

K063110 - CST61 HIGH SPEED TURBINE HANDPIECE

K063110 is an FDA 510(k) clearance for CST61 HIGH SPEED TURBINE HANDPIECE, manufactured by Shanghai Dental Instrument Factory. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K063110 · Shanghai Dental Instrument Factory · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
15d
Days
Class 1
Risk

K063110 is an FDA 510(k) clearance for the CST61 HIGH SPEED TURBINE HANDPIECE. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Shanghai Dental Instrument Factory (Roswell, US). The FDA issued a Cleared decision on October 26, 2006 after a review of 15 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063110

510(k) Number K063110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2006
Decision Date October 26, 2006
Days to Decision 15 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EFB Device Classification - Class 1, General Controls

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 247
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K063110.
HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES
K062947 · Peng Lim Enterprise Co., Ltd. · Dec 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
K062812 · Thunder Tiger Corp. · Nov 2006
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU
K062740 · Jindell Medical Instruments Co., Ltd. · Nov 2006
K-SPRAY, MODEL 085-2715
K062418 · Scican · Oct 2006
PRODRIVE SYSTEMS REPLACEMENT TURBINE
K062219 · Prodrive Systems, Inc. · Aug 2006
INTERPROXIMAL REDUCTION SYSTEM
K053368 · Dentsply International · Mar 2006
K063110 · CST61 HIGH SPEED TURBINE HANDPIECE
Download PDF FDA Summary Shanghai Dental Instr…