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FDA 510(k)

STERILE FLEXOFILE FILES AND INSTRUMENTS

K-Number: K971606 · 1997-06-03

ApplicantDentsply Intl.
Decision Date1997-06-03
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STERILE FLEXOFILE FILES AND INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1997-06-03 under 510(k) number K971606. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE FLEXOFILE FILES AND INSTRUMENTS?

STERILE FLEXOFILE FILES AND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1997-06-03. The listed applicant is Dentsply Intl.. The 510(k) number is K971606.

When did STERILE FLEXOFILE FILES AND INSTRUMENTS receive FDA 510(k) clearance?

STERILE FLEXOFILE FILES AND INSTRUMENTS received FDA 510(k) clearance on 1997-06-03, under 510(k) number K971606.

Who is the listed applicant for STERILE FLEXOFILE FILES AND INSTRUMENTS?

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

What is the FDA product code for STERILE FLEXOFILE FILES AND INSTRUMENTS?

The FDA product code for STERILE FLEXOFILE FILES AND INSTRUMENTS is EFA.

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Related Devices (Code: EFA)

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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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