Micro RSH High Speed Handpiece
FDA 510(k) K935676 · Micro Motors, Inc.
510(k) numberK935676
Submission
- Device name
- Micro RSH High Speed Handpiece
- Applicant
- Micro Motors, Inc.
Santa Ana, CA, US - Received
- November 26, 1993
- Decision date
- March 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K000120 | Pro-TorqEBW · Special | 02/03/2000SE |
| K991283 | Dyna Torq Torque Wrench, Torque WrenchDZE · Traditional | 08/18/1999SE |
| K963843 | Electric Surgical Irrigation System - Dual Controller UnitEFB · Traditional | 03/31/1997SE |
| K970002 | Sterile Water PumpEIA · Traditional | 03/05/1997SE |
| K942380 | Micro Ics Sonic ScalerELC · Traditional | 08/07/1995SE |
| K911068 | 29540 Dynasurg Electric Handpiece and Irr. SystemEFB · Traditional | 05/15/1991SE |
| K903298 | Dynasonic Plaque Remover & Polisher DynatipELC · Traditional | 04/16/1991SE |
| K904850 | Dual and Single Irr. Systems Models 29550 & 29555EFS · Traditional | 01/25/1991SE |
| K896878 | Handpiece System with Motor (Several Models)EFB · Traditional | 03/08/1990SE |
| K896879 | Oral Surgery Handpiece and AttachmentsEFB · Traditional | 03/07/1990SE |
Questions and answers
When was Micro RSH High Speed Handpiece cleared by the FDA?
Micro RSH High Speed Handpiece (K935676) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 490 days after the submission was received.
What is the product code of K935676?
The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.