Schein AP-1 Air Polishing Unit
FDA 510(k) K862384 · Henry Schein, Inc.
510(k) numberK862384
Submission
- Device name
- Schein AP-1 Air Polishing Unit
- Applicant
- Henry Schein, Inc.
Port Washington, NY, US - Received
- June 24, 1986
- Decision date
- November 7, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
More from Deldent , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K041580 | ImagerayiMUH · Traditional | 06/29/2004SE |
| K862385 | Schein Bleaching UnitEEG · Traditional | 10/30/1986SE |
| K841199 | Fiberglass Mouth MirrorsEAX · Traditional | 04/25/1984SE |
| K834055 | Vanadium Excavators Sizes 0-6EKC · Traditional | 02/21/1984SE |
| K834056 | Schein Cotton Rolls, Non-SterileEFN · Traditional | 02/03/1984SE |
| K801079 | Kwix-Bite X-Ray Film HolderEGZ · Traditional | 05/20/1980SE |
| K781592 | Surgical Aspirator TipsDYN · Traditional | 12/04/1978SE |
Questions and answers
When was Schein AP-1 Air Polishing Unit cleared by the FDA?
Schein AP-1 Air Polishing Unit (K862384) received a 510(k) decision of Substantially Equivalent on November 7, 1986, 136 days after the submission was received.
What is the product code of K862384?
The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.