Sealdent
FDA 510(k) K944466 · Scientific Pharmaceuticals, Inc.
510(k) numberK944466
Submission
- Device name
- Sealdent
- Applicant
- Scientific Pharmaceuticals, Inc.
Pomona, CA, US - Received
- September 7, 1994
- Decision date
- March 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
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| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
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| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
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| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
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| 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 |
| K930584 | MagnacoreEBF · Traditional | 02/22/1994SE |
Questions and answers
When was Sealdent cleared by the FDA?
Sealdent (K944466) received a 510(k) decision of Substantially Equivalent on March 2, 1995, 176 days after the submission was received.
What is the product code of K944466?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.