Universum
FDA 510(k) K900946 · Scientific Pharmaceuticals, Inc.
510(k) numberK900946
Submission
- Device name
- Universum
- Applicant
- Scientific Pharmaceuticals, Inc.
Duarte, CA, US - Received
- March 1, 1990
- Decision date
- May 25, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| 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 |
|---|---|---|
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…LBH · Traditional | 02/18/2020SE |
| K051952 | EugenoneEMA · Traditional | 09/07/2005SE |
| K041886 | ProvisoEBG · Traditional | 08/04/2004SE |
| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
| K001446 | Light-Cured Orthodontic Band CementDYH · Traditional | 07/21/2000SE |
| K993324 | Carbocem Zinc Polycarboxylate CementEMA · Traditional | 11/09/1999SE |
| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | 12/17/1998SE |
| K982913 | Zinfos Zinc Phosphate CementEMA · Traditional | 10/19/1998SE |
| K944466 | SealdentEBI · Traditional | 03/02/1995SE |
Questions and answers
When was Universum cleared by the FDA?
Universum (K900946) received a 510(k) decision of Substantially Equivalent on May 25, 1990, 85 days after the submission was received.
What is the product code of K900946?
The FDA product code is LBH – Varnish, Cavity, a Class II (moderate risk) device regulated under 21 CFR 872.3260.