Oral Surgery Contra
FDA 510(k) K211584 · Nakanishi, Inc.
510(k) numberK211584
Submission
- Device name
- Oral Surgery Contra
- Applicant
- Nakanishi, Inc.
Kanuma, JP - Received
- May 24, 2021
- Decision date
- August 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KMW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171155 | Surgical Angle Handpiece, Surgical Straight HandpieceKMW · Traditional | Nakanishi, Inc. | 11/21/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | Osteomed | 04/04/2017SE |
| K080939 | Surgical Handpieces, Mikro Saw HandpiecesKMW · Traditional | W&H Dentalwerk Buermoos GmbH | 07/29/2008SE |
| K994298 | Frios MicrosawKMW · Traditional | Friadent GmbH | 02/18/2000SE |
| K971692 | Osteopower System and AccessoriesKMW · Traditional | Osteomed Corp. | 06/27/1997SE |
| K970953 | E-Type Speed Reducer Contra AngleKMW · Traditional | Nsk Nakanishi, Inc. | 04/15/1997SE |
| K932255 | Young D'GranulatorKMW · Traditional | Young Dental Manufacturing Co. 1, LLC | 04/15/1994SE |
| K862110 | Osseodent Drilling SystemKMW · Traditional | Otc/America | 08/07/1986SE |
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Questions and answers
When was Oral Surgery Contra cleared by the FDA?
Oral Surgery Contra (K211584) received a 510(k) decision of Substantially Equivalent on August 19, 2021, 87 days after the submission was received.
What is the product code of K211584?
The FDA product code is KMW – Handpiece, Rotary Bone Cutting, a Class II (moderate risk) device regulated under 21 CFR 872.4120.