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FDA 510(k)

ORALVUE DENTAL MIRROR

K-Number: K946073 · 1995-02-16

ApplicantHines Group , Ltd.
Decision Date1995-02-16
Product CodeEAX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALVUE DENTAL MIRROR is the device name listed in this FDA 510(k) record. The listed applicant is Hines Group , Ltd.. It received FDA 510(k) clearance on 1995-02-16 under 510(k) number K946073. The device is classified under product code EAX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALVUE DENTAL MIRROR?

ORALVUE DENTAL MIRROR is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is Hines Group , Ltd.. The 510(k) number is K946073.

When did ORALVUE DENTAL MIRROR receive FDA 510(k) clearance?

ORALVUE DENTAL MIRROR received FDA 510(k) clearance on 1995-02-16, under 510(k) number K946073.

Who is the listed applicant for ORALVUE DENTAL MIRROR?

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

What is the FDA product code for ORALVUE DENTAL MIRROR?

The FDA product code for ORALVUE DENTAL MIRROR is EAX.

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Related Devices (Code: EAX)

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.

K935906RANIR PLAX RXRanir/Dcp Corp.K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.K935687NILDentalsafe Systems Pty., Ltd.K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.K833310FOGCUTTER DENTAL MOUTH MIRRORHti, Inc.

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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