Pisces Plus (DW286 C)
FDA 510(k) K020183 · Ivoclar Vivadent, Inc.
510(k) numberK020183
Submission
- Device name
- Pisces Plus (DW286 C)
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- January 18, 2002
- Decision date
- March 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Pisces Plus (DW286 C) cleared by the FDA?
Pisces Plus (DW286 C) (K020183) received a 510(k) decision of Substantially Equivalent on March 13, 2002, 54 days after the submission was received.
What is the product code of K020183?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.