Prilane
FDA 510(k) K981524 · Gresco Products, Inc.
510(k) numberK981524
Submission
- Device name
- Prilane
- Applicant
- Gresco Products, Inc.
Stafford, TX, US - Received
- April 28, 1998
- Decision date
- July 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K913405 | Kar-D-TekLFC · Traditional | 10/28/1991SE |
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| K901973 | CP-3 Dental Polishing MaterialEJR · Traditional | 06/01/1990SE |
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Questions and answers
When was Prilane cleared by the FDA?
Prilane (K981524) received a 510(k) decision of Substantially Equivalent on July 10, 1998, 73 days after the submission was received.
What is the product code of K981524?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.