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FDA 510(k)

MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL

K-Number: K060270 · 2006-04-10

ApplicantLinvatec Corp.
Decision Date2006-04-10
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K060270. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL?

MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Linvatec Corp.. The 510(k) number is K060270.

When did MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL receive FDA 510(k) clearance?

MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL received FDA 510(k) clearance on 2006-04-10, under 510(k) number K060270.

Who is the listed applicant for MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL?

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

What is the FDA product code for MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL?

The FDA product code for MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL is DZI.

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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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