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FDA 510(k)

SOLO ORTHO

K-Number: K990743 · 1999-06-04

ApplicantSybron Dental Specialties, Inc.
Decision Date1999-06-04
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLO ORTHO is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1999-06-04 under 510(k) number K990743. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLO ORTHO?

SOLO ORTHO is a medical device that received FDA 510(k) clearance on 1999-06-04. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K990743.

When did SOLO ORTHO receive FDA 510(k) clearance?

SOLO ORTHO received FDA 510(k) clearance on 1999-06-04, under 510(k) number K990743.

Who is the listed applicant for SOLO ORTHO?

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

What is the FDA product code for SOLO ORTHO?

The FDA product code for SOLO ORTHO is DYH.

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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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