Handpiece, Rotary Bone Cutting
A Rotary Bone Cutting Handpiece is a powered dental instrument used in oral surgery and implantology to cut, shape, and prepare bone tissue for procedures such as tooth extraction, implant placement, and orthognathic surgery. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KMW and it is regulated under 21 CFR 872.4120 in the Dental specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KMW
- Device Class
- FDA class 2
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211584 | Oral Surgery Contra | Aug 19, 2021 | Substantially Equivalent | Nakanishi, Inc. |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nov 21, 2017 | Substantially Equivalent | Nakanishi, Inc. |
| K162544 | OsteoMed PINNACLE Driver | Apr 04, 2017 | Substantially Equivalent | Osteomed |
| K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | Jul 29, 2008 | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH |
| K994298 | FRIOS MICROSAW | Feb 18, 2000 | Substantially Equivalent | Friadent GmbH |
| K971692 | OSTEOPOWER SYSTEM AND ACCESSORIES | Jun 27, 1997 | Substantially Equivalent | Osteomed Corp. |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Apr 15, 1997 | Substantially Equivalent | Nsk Nakanishi, Inc. |
| K932255 | YOUNG D'GRANULATOR | Apr 15, 1994 | Substantially Equivalent | Young Dental Manufacturing Co. 1, LLC |
| K862110 | OSSEODENT DRILLING SYSTEM | Aug 07, 1986 | Substantially Equivalent | Otc/America |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.