Nu-Cap Calcium Hydrox. Pulp Capping
FDA 510(k) K831575 · Coe Laboratories, Inc.
510(k) numberK831575
Submission
- Device name
- Nu-Cap Calcium Hydrox. Pulp Capping
- Applicant
- Coe Laboratories, Inc.
Mchenry, IL, US - Received
- May 16, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Nu-Cap Calcium Hydrox. Pulp Capping cleared by the FDA?
Nu-Cap Calcium Hydrox. Pulp Capping (K831575) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 45 days after the submission was received.
What is the product code of K831575?
The FDA product code is EJK – Liner, Cavity, Calcium Hydroxide, a Class II (moderate risk) device regulated under 21 CFR 872.3250.