510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991701Substantially Equivalent

Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma Mu (Mini Head), Mach-Sigma Su (Std. Head), Mach-Sigma Tu (Torque Hd)

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

K991701 is the FDA 510(k) clearance record for MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD), a class I device, cleared for Nsk Nakanishi, Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list 13 510(k) clearances for Nsk Nakanishi, Inc., from to . As of , FDA records show no recalls naming K991701.

Clearance record

Decision date
Received
(83 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
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 EFB

Trailing 12 months
3 clearances under product code EFB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260