Cleared Traditional

K062812 - DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N

K062812 is an FDA 510(k) clearance for DENTAL AIR-POWERED HANDPIECE, manufactured by Thunder Tiger Corp.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K062812 · Thunder Tiger Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
70d
Days
Class 1
Risk

K062812 is an FDA 510(k) clearance for the DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Thunder Tiger Corp. (Hsin Chu City, TW). The FDA issued a Cleared decision on November 28, 2006 after a review of 70 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 - K062812

510(k) Number K062812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2006
Decision Date November 28, 2006
Days to Decision 70 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
58d faster than avg
Panel avg: 128d · This submission: 70d
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 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K062812.
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K062812 · DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
Download PDF FDA Summary Thunder Tiger Corp.