Cleared Traditional

K030603 - PROANGLE DISPOSABLE PROPHY ANGLE

K030603 is an FDA 510(k) clearance for PROANGLE DISPOSABLE PROPHY ANGLE, manufactured by Pac-Dent International (Suzhou), Ltd.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K030603 · Pac-Dent International (Suzhou), Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
48d
Days
Class 1
Risk

K030603 is an FDA 510(k) clearance for the PROANGLE DISPOSABLE PROPHY ANGLE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Pac-Dent International (Suzhou), Ltd. (Jiangsu Province, CN). The FDA issued a Cleared decision on April 14, 2003 after a review of 48 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 - K030603

510(k) Number K030603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date April 14, 2003
Days to Decision 48 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
80d faster than avg
Panel avg: 128d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

EGS Device Classification - Class 1, General Controls

Product Code EGS Handpiece, Contra- And Right-angle Attachment, 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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 67
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K030603 · PROANGLE DISPOSABLE PROPHY ANGLE
Download PDF FDA Summary Pac-Dent Internationa…