Restore Toothpaste
FDA 510(k) K181965 · Dr. Collins, Inc.
510(k) numberK181965
Submission
- Device name
- Restore Toothpaste
- Applicant
- Dr. Collins, Inc.
Irvine, CA, US - Received
- July 23, 2018
- Decision date
- June 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|
| K200077 | BioMin Restore PlusLBH · Traditional | 11/06/2020SE |
Questions and answers
When was Restore Toothpaste cleared by the FDA?
Restore Toothpaste (K181965) received a 510(k) decision of Substantially Equivalent on June 13, 2019, 325 days after the submission was received.
What is the product code of K181965?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.