Cleared Traditional

K972436 - T1 LINE DENTAL HANDPIECES

K972436 is an FDA 510(k) clearance for T1 LINE DENTAL HANDPIECES, manufactured by Siemens AG. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K972436 · Siemens AG · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
84d
Days
Class 1
Risk

K972436 is an FDA 510(k) clearance for the T1 LINE DENTAL HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Siemens AG (North Attleboro, US). The FDA issued a Cleared decision on September 22, 1997 after a review of 84 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 - K972436

510(k) Number K972436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date September 22, 1997
Days to Decision 84 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
44d faster than avg
Panel avg: 128d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, 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 - EFB Handpiece, Air-powered, Dental

All 222
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