Occlude
FDA 510(k) K912632 · Pascal Co., Inc.
510(k) numberK912632
Submission
- Device name
- Occlude
- Applicant
- Pascal Co., Inc.
Bellevue, WA, US - Received
- June 14, 1991
- Decision date
- January 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K965026 | Pfingst Pressure PasteEFH · Traditional | Pfingst & Co., Inc. | 02/10/1997SE |
| K911259 | HydentEFH · Traditional | Pascal Co., Inc. | 06/06/1991SE |
| K864572 | FixtectorEFH · Traditional | Prodent Intl., Inc. | 02/12/1987SE |
| K870032 | Revised T-Scan SystemEFH · Traditional | Sentek, Inc. | 02/02/1987SE |
| K832647 | Articulating PaperEFH · Traditional | Ardent Intl., Inc. | 02/21/1984SE |
| K833132 | Mucosal Adjustment Paste Liquid SprayEFH · Traditional | Myo-Tronics Research, Inc. | 02/10/1984SE |
| K810498 | Centric (Bite) Registration PasteEFH · Traditional | Wallace A. Erickson & Co. | 03/17/1981SE |
| K771011 | Articulating PaperEFH · Traditional | Parker Laboratories, Inc. | 06/20/1977SE |
| K770492 | Crack Detector, Den-MatEFH · Traditional | Dey-Mat, Inc. | 03/21/1977SE |
More from Dey-Mat, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K102526 | BLO2X Oxygen BlockerEBF · Traditional | 10/22/2010SE |
| K090597 | Fluorilaq Sodium Fluoride Cavity VarnishLBH · Special | 03/16/2009SE |
| K040988 | Zircon-F Prophylaxis PasteEJR · Traditional | 07/07/2004SE |
| K040661 | Radent Prophy PasteEJR · Traditional | 06/09/2004SE |
| K012889 | Banicide Liquid Chemical Sterilant/High-Level DisinfectantMED · Traditional | 05/27/2003SE |
| K030488 | FluorilaqLBH · Traditional | 05/02/2003SE |
| K911259 | HydentEFH · Traditional | 06/06/1991SE |
Questions and answers
When was Occlude cleared by the FDA?
Occlude (K912632) received a 510(k) decision of Substantially Equivalent on January 17, 1992, 217 days after the submission was received.
What is the product code of K912632?
The FDA product code is EFH – Paper, Articulation, a Class I (low risk) device regulated under 21 CFR 872.6140.