Self-Curing Hard Denture Liner
FDA 510(k) K820673 · Coe Laboratories, Inc.
510(k) numberK820673
Submission
- Device name
- Self-Curing Hard Denture Liner
- Applicant
- Coe Laboratories, Inc.
Mchenry, IL, US - Received
- March 11, 1982
- Decision date
- April 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Self-Curing Hard Denture Liner cleared by the FDA?
Self-Curing Hard Denture Liner (K820673) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 29 days after the submission was received.
What is the product code of K820673?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.