Spectrum Curing Light Polymerization Unit
FDA 510(k) K951425 · Dentsply Intl.
510(k) numberK951425
Submission
- Device name
- Spectrum Curing Light Polymerization Unit
- Applicant
- Dentsply Intl.
York, PA, US - Received
- March 27, 1995
- Decision date
- May 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Spectrum Curing Light Polymerization Unit cleared by the FDA?
Spectrum Curing Light Polymerization Unit (K951425) received a 510(k) decision of Substantially Equivalent on May 5, 1995, 39 days after the submission was received.
What is the product code of K951425?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.