Duraflor
FDA 510(k) K961893 · Pharmascience, Inc.
510(k) numberK961893
Submission
- Device name
- Duraflor
- Applicant
- Pharmascience, Inc.
Severn, MD, US - Received
- May 16, 1996
- Decision date
- August 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
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| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
More from Jasberry Healthcare Private Limited
| 510(k) | Device | Decision |
|---|---|---|
| K931096 | DuraflorLBH · Traditional | 05/27/1993SE |
Questions and answers
When was Duraflor cleared by the FDA?
Duraflor (K961893) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 90 days after the submission was received.
What is the product code of K961893?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.