Prisma III
FDA 510(k) K832320 · Dentsply Intl.
510(k) numberK832320
Submission
- Device name
- Prisma III
- Applicant
- Dentsply Intl.
Mchenry, IL, US - Received
- July 15, 1983
- Decision date
- August 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Prisma III cleared by the FDA?
Prisma III (K832320) received a 510(k) decision of Substantially Equivalent on August 31, 1983, 47 days after the submission was received.
What is the product code of K832320?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.