Simplex Airbrator (SAB-7)
FDA 510(k) K980672 · Irt Management Corp.
510(k) numberK980672
Submission
- Device name
- Simplex Airbrator (SAB-7)
- Applicant
- Irt Management Corp.
Hallandale, FL, US - Received
- February 20, 1998
- Decision date
- May 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K033215 | PrepairKOJ · Traditional | Danville Materials, Inc. | 01/09/2004SE |
| K024105 | Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional | Velopex International, Inc. | 10/09/2003SE |
| K030292 | Groman PrepmasterKOJ · Traditional | Groman, Inc. | 04/15/2003SE |
| K021450 | Clinpro Prophy PowderKOJ · Traditional | 3M Espe AG Dental Products | 08/01/2002SE |
| K014188 | New Prophy PowderKOJ · Traditional | Dentsply Intl. | 03/15/2002SE |
| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
More from Deldent , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K980783 | Simplex Saliva Absorber/Collector, Model SSA-5KHR · Traditional | 04/21/1998SE |
Questions and answers
When was Simplex Airbrator (SAB-7) cleared by the FDA?
Simplex Airbrator (SAB-7) (K980672) received a 510(k) decision of Substantially Equivalent on May 4, 2000, 804 days after the submission was received.
What is the product code of K980672?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.