Cleared Traditional

K251425 - turbodent touch

K251425 is an FDA 510(k) clearance for turbodent touch, manufactured by Mectron S.P.A.. The device is a Class 2 Dental device with product code KOJ cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K251425 · Mectron S.P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
1d
Days
Class 2
Risk

K251425 is an FDA 510(k) clearance for the turbodent touch. Classified as Airbrush (product code KOJ), Class II - Special Controls.

Submitted by Mectron S.P.A. (Carasco, IT). The FDA issued a Cleared decision on May 9, 2025 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6080 - 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 Mectron S.P.A. devices

FDA 510(k) Submission Details - K251425

510(k) Number K251425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2025
Decision Date May 09, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 127d · This submission: 1d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KOJ Device Classification - Class 2, Special Controls

Product Code KOJ Airbrush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6080
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KOJ Airbrush

All 7
Devices cleared under the same product code (KOJ) and FDA review panel - the closest regulatory comparables to K251425.
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
K033675 · Sirona Dental Systems GmbH · Jan 2004
CLINPRO PROPHY POWDER
K021450 · 3M Espe AG Dental Products · Aug 2002
NEW PROPHY POWDER
K014188 · Dentsply Intl. · Mar 2002
ULTRA-BLASTER
K980726 · Ultradent Products, Inc. · May 1998
AEROETCHER
K973679 · Parkell, Inc. · Mar 1998
ACCU-PREP
K970484 · Bisco, Inc. · Jul 1997