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FDA 510(k)

HERCULITE ULTRA

K-Number: K082671 · 2008-12-11

ApplicantSybron Dental Specialties
Decision Date2008-12-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERCULITE ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties. It received FDA 510(k) clearance on 2008-12-11 under 510(k) number K082671. 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 ULTRA?

HERCULITE ULTRA is a medical device that received FDA 510(k) clearance on 2008-12-11. The listed applicant is Sybron Dental Specialties. The 510(k) number is K082671.

When did HERCULITE ULTRA receive FDA 510(k) clearance?

HERCULITE ULTRA received FDA 510(k) clearance on 2008-12-11, under 510(k) number K082671.

Who is the listed applicant for HERCULITE ULTRA?

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

What is the FDA product code for HERCULITE ULTRA?

The FDA product code for HERCULITE ULTRA is EBF.

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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