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FDA 510(k)

DEMETRON A.2

K-Number: K063116 · 2006-12-05

ApplicantSybron Dental Specialties
Decision Date2006-12-05
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEMETRON A.2 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 2006-12-05 under 510(k) number K063116. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMETRON A.2?

DEMETRON A.2 is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Sybron Dental Specialties. The 510(k) number is K063116.

When did DEMETRON A.2 receive FDA 510(k) clearance?

DEMETRON A.2 received FDA 510(k) clearance on 2006-12-05, under 510(k) number K063116.

Who is the listed applicant for DEMETRON A.2?

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 DEMETRON A.2?

The FDA product code for DEMETRON A.2 is EBZ.

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Related Devices (Code: EBZ)

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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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