510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KMWClass II

Handpiece, Rotary Bone Cutting

21 CFR 872.4120 / Dental
FDA source (opens on fda.gov)

KMW is the FDA product code for Handpiece, Rotary Bone Cutting, a class II device type, regulated under 21 CFR 872.4120. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
KMW
Device name
Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
10

Clearances, product code KMW

By decision year
9 clearances under product code KMW with a decision year between 1986 and 2021, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KMW by decision year
YearClearances
19861
19941
19972
20001
20081
20172
20211

Applicants with the most clearances

Product code KMW
Applicants holding the most 510(k) clearances under product code KMW
ApplicantClearances
Nakanishi Inc.2
Osteomed2
Friadent GmbH1
Nsk Nakanishi, Inc.1
Otc/America1
W & H DentalWerk Buermoos GmbH1
Young Dental Manufacturing Co 1, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order