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FDA 510(k)

DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980

K-Number: K063384 · 2007-03-16

ApplicantHoya Conbio, Inc.
Decision Date2007-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Conbio, Inc.. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K063384. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980?

DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Hoya Conbio, Inc.. The 510(k) number is K063384.

When did DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 receive FDA 510(k) clearance?

DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 received FDA 510(k) clearance on 2007-03-16, under 510(k) number K063384.

Who is the listed applicant for DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980?

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

What is the FDA product code for DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980?

The FDA product code for DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980 is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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