Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/US

FDA 510(k) K072643 · Olympus Corporation

Substantially Equivalent

510(k) numberK072643

Submission

Device name
Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/US
Applicant
Olympus Corporation
Tokyo, JP
Received
September 18, 2007
Decision date
November 16, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KZN – Scanner, Color
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3661
Specialty
Dental

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Questions and answers

When was Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/US cleared by the FDA?

Crystaleye Spectrophotometer/Crystaleye Basic Set, Model CE100-DC/US (K072643) received a 510(k) decision of Substantially Equivalent on November 16, 2007, 59 days after the submission was received.

What is the product code of K072643?

The FDA product code is KZN – Scanner, Color, a Class II (moderate risk) device regulated under 21 CFR 872.3661.