Frios Microsaw
FDA 510(k) K994298 · Friadent GmbH
510(k) numberK994298
Submission
- Device name
- Frios Microsaw
- Applicant
- Friadent GmbH
Lake Forest, CA, US - Received
- December 21, 1999
- Decision date
- February 18, 2000
- 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 |
|---|---|---|---|
| K211584 | Oral Surgery ContraKMW · Traditional | Nakanishi, Inc. | 08/19/2021SE |
| 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 |
| 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 |
More from Otc/America
| 510(k) | Device | Decision |
|---|---|---|
| K040170 | Friadent Plus Dental Implant SystemsDZE · Traditional | 10/27/2004SE |
| K041509 | Ankylos Dental Implant SystemDZE · Traditional | 08/26/2004SE |
| K040946 | Ankylos Dental Implant SystemDZE · Traditional | 07/01/2004SE |
| K032302 | Xive TG AbutmentsDZE · Traditional | 10/02/2003SE |
| K032284 | Xive TG Dental Implant SystemDZE · Special | 08/14/2003SE |
| K032158 | Xive Dental Implant System MultipleDZE · Special | 08/14/2003SE |
| K031674 | Modification to FRIALIT-2 Dental Implant SystemDZE · Special | 08/14/2003SE |
| K024004 | Xive Transgingival Dental Implant SystemDZE · Special | 03/03/2003SE |
| K023799 | Frios AlgiporeLYC · Traditional | 02/05/2003SE |
| K021318 | Xive Dental Implant SystemDZE · Traditional | 07/02/2002SE |
Questions and answers
When was Frios Microsaw cleared by the FDA?
Frios Microsaw (K994298) received a 510(k) decision of Substantially Equivalent on February 18, 2000, 59 days after the submission was received.
What is the product code of K994298?
The FDA product code is KMW – Handpiece, Rotary Bone Cutting, a Class II (moderate risk) device regulated under 21 CFR 872.4120.