Cleared Traditional

K023953 - ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE

K023953 is an FDA 510(k) clearance for ST. GEORGE TECHNOLOGY, manufactured by St. George Technology, Inc.. The device is a Class 1 Dental device with product code EGS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K023953 · St. George Technology, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
79d
Days
Class 1
Risk

K023953 is an FDA 510(k) clearance for the ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by St. George Technology, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 14, 2003 after a review of 79 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 - K023953

510(k) Number K023953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2002
Decision Date February 14, 2003
Days to Decision 79 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
49d faster than avg
Panel avg: 128d · This submission: 79d
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 64
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K023953.
B&R DEVICE
K032925 · Ronvig A/S · Dec 2003
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
K022505 · NOUVAG AG · Oct 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · Pac-Dent International (Suzhou), Ltd. · Apr 2003
CLEAN 'N' OIL
K022264 · Svenska Dental Instruments AB · Oct 2002
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON
K020137 · Aseptico, Inc. · Mar 2002
SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
K011061 · W&H Dentalwerk Buermoos GmbH · Jun 2001
K023953 · ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
Download PDF FDA Summary St. George Technology…