Cleared Traditional

K072643 - CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE...

K072643 is an FDA 510(k) clearance for CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE..., manufactured by Olympus Corporation. The device is a Class 2 Dental device with product code KZN cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K072643 · Olympus Corporation · Dental device
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Nov 2007
Decision
59d
Days
Class 2
Risk

K072643 is an FDA 510(k) clearance for the CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US. Classified as Scanner, Color (product code KZN), Class II - Special Controls.

Submitted by Olympus Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 16, 2007 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3661 - 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 Olympus Corporation devices

FDA 510(k) Submission Details - K072643

510(k) Number K072643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2007
Decision Date November 16, 2007
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 127d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZN Device Classification - Class 2, Special Controls

Product Code KZN Scanner, Color
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3661
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.