Coltolux Light Meter
FDA 510(k) K950106 · Coltene/Whaledent, Inc.
510(k) numberK950106
Submission
- Device name
- Coltolux Light Meter
- Applicant
- Coltene/Whaledent, Inc.
Mahwah, NJ, US - Received
- January 11, 1995
- Decision date
- May 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Coltolux Light Meter cleared by the FDA?
Coltolux Light Meter (K950106) received a 510(k) decision of Substantially Equivalent on May 24, 1995, 133 days after the submission was received.
What is the product code of K950106?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.