Cleared Traditional

K042759 - OPTIMA MX

K042759 is an FDA 510(k) clearance for OPTIMA MX, manufactured by Bien-Air SA Switzerland. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K042759 · Bien-Air SA Switzerland · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
15d
Days
Class 1
Risk

K042759 is an FDA 510(k) clearance for the OPTIMA MX. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Bien-Air SA Switzerland (Bienne 6, CH). The FDA issued a Cleared decision on October 20, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 - K042759

510(k) Number K042759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2004
Decision Date October 20, 2004
Days to Decision 15 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
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 Consultant

Citech
ERIN SPARNON

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 - EIA Unit, Operative Dental

All 277
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K042759.
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K042759 · OPTIMA MX
Download PDF FDA Summary Bien-Air SA Switzerla…