FDA product code KMW: Handpiece, Rotary Bone Cutting
KMW is the FDA product code for handpiece, rotary bone cutting. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel. FDA has cleared 9 510(k) submissions under KMW, from 8 different applicants. The average 510(k) review took 130 days (median 87). FDA has posted 10 recalls for KMW devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Handpiece, Rotary Bone Cutting |
| Device class | Class II |
| Regulation | 21 CFR 872.4120 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KMW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 210 |
| 2021 | 1 | 87 |
Compare with all 510(k) review times · Search every KMW clearance
Top KMW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nakanishi, Inc. | 2 | 2021-08-19 |
| Osteomed | 1 | 2017-04-04 |
| W&H Dentalwerk Buermoos GmbH | 1 | 2008-07-29 |
| Friadent GmbH | 1 | 2000-02-18 |
| Osteomed Corp. | 1 | 1997-06-27 |
3 more applicants have KMW clearances. See the full list in Caduvo.
Most recent KMW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211584 | Nakanishi, Inc. | Oral Surgery Contra | 2021-08-19 | 87 |
| K171155 | Nakanishi, Inc. | Surgical Angle Handpiece, Surgical Straight Handpiece | 2017-11-21 | 215 |
| K162544 | Osteomed | OsteoMed PINNACLE Driver | 2017-04-04 | 204 |
| K080939 | W&H Dentalwerk Buermoos GmbH | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | 2008-07-29 | 117 |
| K994298 | Friadent GmbH | FRIOS MICROSAW | 2000-02-18 | 59 |
Recalls for KMW devices
10 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-01-16.
| Year | Recalls |
|---|---|
| 2018 | 8 |
| 2021 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code KMW?
KMW is the FDA product code for handpiece, rotary bone cutting. It is a Class II device, regulated under 21 CFR 872.4120 and reviewed by the Dental panel.
What device class is KMW?
Class II, regulation 21 CFR 872.4120. Typical premarket route: 510(k).
How long does a 510(k) take for product code KMW?
Across 9 cleared submissions the average was 130 days from receipt to decision (median 87).
Which companies have the most KMW clearances?
Nakanishi, Inc. (2); Osteomed (1); W&H Dentalwerk Buermoos GmbH (1); Friadent GmbH (1); Osteomed Corp. (1).
Have KMW devices been recalled?
Yes: 10 product recalls across 3 recall events; the most recent began 2024-01-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KMW
- Run a recall and safety report across every KMW manufacturer
- Watch product code KMW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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