Flex-Star V
FDA 510(k) K072402 · Cmp Industries, LLC
510(k) numberK072402
Submission
- Device name
- Flex-Star V
- Applicant
- Cmp Industries, LLC
Albany, NY, US - Received
- August 27, 2007
- Decision date
- October 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K033020 | Impak Acrylic Repair Resin LiquidEBI · Traditional | 12/19/2003SE |
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Questions and answers
When was Flex-Star V cleared by the FDA?
Flex-Star V (K072402) received a 510(k) decision of Substantially Equivalent on October 19, 2007, 53 days after the submission was received.
What is the product code of K072402?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.