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FDA 510(k)

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900

K-Number: K110278 · 2012-02-15

ApplicantNakanishi, Inc.
Decision Date2012-02-15
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2012-02-15 under 510(k) number K110278. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900?

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 is a medical device that received FDA 510(k) clearance on 2012-02-15. The listed applicant is Nakanishi, Inc.. The 510(k) number is K110278.

When did CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 receive FDA 510(k) clearance?

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 received FDA 510(k) clearance on 2012-02-15, under 510(k) number K110278.

Who is the listed applicant for CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900?

The FDA 510(k) record lists Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900?

The FDA product code for CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 is EKX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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