Cleared Traditional

K090055 - LOW & HIGH SPEED KIT

K090055 is an FDA 510(k) clearance for LOW & HIGH SPEED KIT, manufactured by Dpm USA Corp.. The device is a Class 1 Dental device with product code EFA cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K090055 · Dpm USA Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
292d
Days
Class 1
Risk

K090055 is an FDA 510(k) clearance for the LOW & HIGH SPEED KIT. Classified as Handpiece, Belt And/or Gear Driven, Dental (product code EFA), Class I - General Controls.

Submitted by Dpm USA Corp. (Miami, US). The FDA issued a Cleared decision on October 27, 2009 after a review of 292 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 - K090055

510(k) Number K090055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2009
Decision Date October 27, 2009
Days to Decision 292 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
164d slower than avg
Panel avg: 128d · This submission: 292d
Pathway characteristics
Predicate-based equivalence.

EFA Device Classification - Class 1, General Controls

Product Code EFA Handpiece, Belt And/or Gear Driven, 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 - EFA Handpiece, Belt And/or Gear Driven, Dental

All 22
Devices cleared under the same product code (EFA) and FDA review panel - the closest regulatory comparables to K090055.
RDT3 HANDPIECE HEAD MODEL RDT3
K101172 · Redent-Nova , Ltd. · Jul 2010
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K093894 · Anthogyr · Mar 2010
INTRA LUX HEAD 3 LDSY
K092446 · Kaltenbach & Voigt GmbH & Co. · Nov 2009
STRONG IMPLANT HANDPIECES
K092412 · Saeshin Precision Co., Ltd. · Sep 2009
MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
K090676 · Anthogyr · May 2009
MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL
K070084 · Est. Anthogyr · Mar 2007
K090055 · LOW & HIGH SPEED KIT
Download PDF FDA Summary Dpm USA Corp.