Cleared Traditional

K023513 - LOGOS JUNIOR DENTAL CHAIR AND UNIT

K023513 is an FDA 510(k) clearance for LOGOS JUNIOR DENTAL CHAIR AND UNIT, manufactured by Castellini S.P.A.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K023513 · Castellini S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
156d
Days
Class 1
Risk

K023513 is an FDA 510(k) clearance for the LOGOS JUNIOR DENTAL CHAIR AND UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Castellini S.P.A. (Castel Maggiore, Bologna, IT). The FDA issued a Cleared decision on March 26, 2003 after a review of 156 days - an extended review 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: 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 - K023513

510(k) Number K023513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date March 26, 2003
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 128d · This submission: 156d
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 282
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K023513.
INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
K032341 · Sota Precision Optics, Inc. · Aug 2003
C-1805M
K023815 · Anodia Systems · Jun 2003
C-1890
K023896 · Anodia Systems · Jun 2003
RDH-2000
K023213 · Anodia Systems · Jan 2003
AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM
K022217 · Aseptico, Inc. · Oct 2002
VERACAM
K021083 · Lumalite, Inc. · Aug 2002
K023513 · LOGOS JUNIOR DENTAL CHAIR AND UNIT
Download PDF Castellini S.P.A.