Cleared Traditional

K130455 - 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES

K130455 is an FDA 510(k) clearance for 430 SWL 45 AND 430 SW 45 HIGH-SPEED HAN..., manufactured by Dentalez Group, Stardental Division. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K130455 · Dentalez Group, Stardental Division · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
215d
Days
Class 1
Risk

K130455 is an FDA 510(k) clearance for the 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Dentalez Group, Stardental Division (Lancaster, US). The FDA issued a Cleared decision on September 25, 2013 after a review of 215 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130455

510(k) Number K130455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2013
Decision Date September 25, 2013
Days to Decision 215 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
87d slower than avg
Panel avg: 128d · This submission: 215d
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 K130455.
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K130455 · 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES
Download PDF FDA Summary Dentalez Group, Stard…