Cleared Traditional

K071485 - TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888

K071485 is an FDA 510(k) clearance for TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, manufactured by Tpc Advanced Technology, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K071485 · Tpc Advanced Technology, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
90d
Days
Class 1
Risk

K071485 is an FDA 510(k) clearance for the TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Tpc Advanced Technology, Inc. (City Of Industry, US). The FDA issued a Cleared decision on August 28, 2007 after a review of 90 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K071485

510(k) Number K071485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2007
Decision Date August 28, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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 Peers - EIA Unit, Operative Dental

All 261
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K071485.
WESTAR SERIES DENTAL UNITS
K082294 · Westar Medical Products, Inc. · Aug 2008
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
K080677 · Kaltenbach & Voigt GmbH & Co. · Jun 2008
DENTAL UNIT WITH CHAIR
K080438 · North West Medical Instrument (Group) Co., Ltd. · Apr 2008
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
K071485 · TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888
Download PDF FDA Summary Tpc Advanced Technolo…