Spectramat
FDA 510(k) K910068 · Ivoclar North America, Inc.
510(k) numberK910068
Submission
- Device name
- Spectramat
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- January 9, 1991
- Decision date
- March 15, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Spectramat cleared by the FDA?
Spectramat (K910068) received a 510(k) decision of Substantially Equivalent on March 15, 1991, 65 days after the submission was received.
What is the product code of K910068?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.