Airflow Handy
FDA 510(k) K991857 · Electro Medical Systems, Inc.
510(k) numberK991857
Submission
- Device name
- Airflow Handy
- Applicant
- Electro Medical Systems, Inc.
North Attleboro, MA, US - Received
- June 1, 1999
- Decision date
- October 7, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800…EFB · Traditional | Litu Tech , Ltd. | 04/30/2024SE |
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More from Ttbio Corp.
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| K022328 | EMS Piezon Master 600ELC · Special | 08/13/2002SE |
| K022119 | EMS Air-Flow Handy 2 Dental HandpieceEFB · Special | 07/25/2002SE |
| K012445 | EMS Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra)FFK · Special | 08/24/2001SE |
| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | 10/04/2000SE |
| K992251 | Swiss Lithoclast Multipurpose ProbeFFK · Special | 07/27/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | 12/16/1996SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Questions and answers
When was Airflow Handy cleared by the FDA?
Airflow Handy (K991857) received a 510(k) decision of Substantially Equivalent on October 7, 1999, 128 days after the submission was received.
What is the product code of K991857?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.