Cleared Traditional

K962979 - S-53 INTRORAL DENTAL SYSTEM

K962979 is an FDA 510(k) clearance for S-53 INTRORAL DENTAL SYSTEM, manufactured by Del Medical Systems Corp.. The device is a Class 1 Dental device with product code DZA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K962979 · Del Medical Systems Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
56d
Days
Class 1
Risk

K962979 is an FDA 510(k) clearance for the S-53 INTRORAL DENTAL SYSTEM. Classified as Drill, Dental, Intraoral (product code DZA), Class I - General Controls.

Submitted by Del Medical Systems Corp. (Valhalla, US). The FDA issued a Cleared decision on September 25, 1996 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4130 - 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.

View all Del Medical Systems Corp. devices

FDA 510(k) Submission Details - K962979

510(k) Number K962979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1996
Decision Date September 25, 1996
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

DZA Device Classification - Class 1, General Controls

Product Code DZA Drill, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4130
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 - DZA Drill, Dental, Intraoral

Devices cleared under the same product code (DZA) and FDA review panel - the closest regulatory comparables to K962979.
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
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