Opti-Lite

FDA 510(k) K844351 · Innovators, Inc.

Substantially Equivalent

510(k) numberK844351

Submission

Device name
Opti-Lite
Applicant
Innovators, Inc.
Jefferson City, MO, US
Received
November 9, 1984
Decision date
December 21, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EBZ – Activator, Ultraviolet, For Polymerization
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6070
Specialty
Dental

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Questions and answers

When was Opti-Lite cleared by the FDA?

Opti-Lite (K844351) received a 510(k) decision of Substantially Equivalent on December 21, 1984, 42 days after the submission was received.

What is the product code of K844351?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.