510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970953Substantially Equivalent

E-Type Speed Reducer Contra Angle

Nsk Nakanishi, Inc., Tochigi-Ken, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970953 is the FDA 510(k) clearance record for E-TYPE SPEED REDUCER CONTRA ANGLE, a class II device, cleared for Nsk Nakanishi, Inc. on under FDA product code KMW (Handpiece, Rotary Bone Cutting). FDA records list 13 510(k) clearances for Nsk Nakanishi, Inc., from to . As of , FDA records show no recalls naming K970953.

Clearance record

Decision date
Received
(29 days to decision)
Product code
KMW Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Nsk Nakanishi, Inc. 340 Kamihinata, Kanuma-Shi, Tochigi-Ken, JP
510(k) summary
Statement
Third party review
No

Clearances, product code KMW

Trailing 12 months

FDA records hold no clearances under product code KMW in the trailing twelve months.

FDA records show no clearances under product code KMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260