Curay Join Dent Dentin Primer
FDA 510(k) K850675 · Scientific Pharmaceuticals, Inc.
510(k) numberK850675
Submission
- Device name
- Curay Join Dent Dentin Primer
- Applicant
- Scientific Pharmaceuticals, Inc.
Duarte, CA, US - Received
- February 21, 1985
- Decision date
- March 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Curay Join Dent Dentin Primer cleared by the FDA?
Curay Join Dent Dentin Primer (K850675) received a 510(k) decision of Substantially Equivalent on March 25, 1985, 32 days after the submission was received.
What is the product code of K850675?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.