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FDA 510(k)

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC

K-Number: K103699 · 2011-08-12

ApplicantExactech, Inc.
Decision Date2011-08-12
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2011-08-12 under 510(k) number K103699. The device is classified under product code NUN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC?

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC is a medical device that received FDA 510(k) clearance on 2011-08-12. The listed applicant is Exactech, Inc.. The 510(k) number is K103699.

When did EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC receive FDA 510(k) clearance?

EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC received FDA 510(k) clearance on 2011-08-12, under 510(k) number K103699.

Who is the listed applicant for EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC?

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

What is the FDA product code for EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC?

The FDA product code for EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC is NUN.

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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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