Caulk Dycal Light Cured
FDA 510(k) K850641 · Dentsply Intl.
510(k) numberK850641
Submission
- Device name
- Caulk Dycal Light Cured
- Applicant
- Dentsply Intl.
York, PA, US - Received
- February 19, 1985
- Decision date
- March 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Caulk Dycal Light Cured cleared by the FDA?
Caulk Dycal Light Cured (K850641) received a 510(k) decision of Substantially Equivalent on March 18, 1985, 27 days after the submission was received.
What is the product code of K850641?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.