Cleared Traditional

K063302 - SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES

K063302 is an FDA 510(k) clearance for SDIF DENTAL CHAIR WITH OPERATIVE UNIT A..., manufactured by Shanghai Dental Instrument Factory. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K063302 · Shanghai Dental Instrument Factory · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
14d
Days
Class 1
Risk

K063302 is an FDA 510(k) clearance for the SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Shanghai Dental Instrument Factory (Buffalo, US). The FDA issued a Cleared decision on November 15, 2006 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 - K063302

510(k) Number K063302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date November 15, 2006
Days to Decision 14 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
114d faster than avg
Panel avg: 128d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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

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 - EIA Unit, Operative Dental

All 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K063302.
OPTI
K063646 · Camsight Co., Inc. · Mar 2007
FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT
K070196 · Hr Dental Products, Inc. · Jan 2007
C-U2
K062897 · Cefla S.C.R.L. · Dec 2006
COMPACT PLUS - EXTREME - PERFECT PLUS
K052574 · J.O. Suarez & Cia, Ltda · Jul 2006
CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
K061175 · Sota Precision Optics, Inc. · May 2006
ABSOLUTE AMERICA
K050571 · Eurodent S.P.A. · Nov 2005
K063302 · SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
Download PDF FDA Summary Shanghai Dental Instr…