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FDA 510(k)

OPTODENT/OPTOGNATH

K-Number: K936058 · 1994-05-16

ApplicantSpectrum Healthcare Group
Decision Date1994-05-16
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTODENT/OPTOGNATH is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Healthcare Group. It received FDA 510(k) clearance on 1994-05-16 under 510(k) number K936058. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTODENT/OPTOGNATH?

OPTODENT/OPTOGNATH is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Spectrum Healthcare Group. The 510(k) number is K936058.

When did OPTODENT/OPTOGNATH receive FDA 510(k) clearance?

OPTODENT/OPTOGNATH received FDA 510(k) clearance on 1994-05-16, under 510(k) number K936058.

Who is the listed applicant for OPTODENT/OPTOGNATH?

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

What is the FDA product code for OPTODENT/OPTOGNATH?

The FDA product code for OPTODENT/OPTOGNATH is ELM.

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Related Devices (Code: ELM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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