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FDA 510(k)

HERCULITE XR & XRV

K-Number: K943642 · 1994-11-17

ApplicantSybron Dental Specialties, Inc.
Decision Date1994-11-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERCULITE XR & XRV is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1994-11-17 under 510(k) number K943642. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERCULITE XR & XRV?

HERCULITE XR & XRV is a medical device that received FDA 510(k) clearance on 1994-11-17. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K943642.

When did HERCULITE XR & XRV receive FDA 510(k) clearance?

HERCULITE XR & XRV received FDA 510(k) clearance on 1994-11-17, under 510(k) number K943642.

Who is the listed applicant for HERCULITE XR & XRV?

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

What is the FDA product code for HERCULITE XR & XRV?

The FDA product code for HERCULITE XR & XRV is EBF.

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Related Devices (Code: EBF)

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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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