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FDA 510(k)

PROPHY PRO.

K-Number: K945834 · 1995-02-13

ApplicantHyman, Phelps & McNamara, P.C.
Decision Date1995-02-13
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY PRO. is the device name listed in this FDA 510(k) record. The listed applicant is Hyman, Phelps & McNamara, P.C.. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K945834. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHY PRO.?

PROPHY PRO. is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Hyman, Phelps & McNamara, P.C.. The 510(k) number is K945834.

When did PROPHY PRO. receive FDA 510(k) clearance?

PROPHY PRO. received FDA 510(k) clearance on 1995-02-13, under 510(k) number K945834.

Who is the listed applicant for PROPHY PRO.?

The FDA 510(k) record lists Hyman, Phelps & McNamara, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROPHY PRO.?

The FDA product code for PROPHY PRO. is EGS.

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Other records listing Hyman, Phelps & McNamara, P.C. as applicant

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.

K950530PRO-TEC-CASEK950878MENICON SP VIALK915574COMFORT PERSONAL LUBRICANT

Related Devices (Code: EGS)

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.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) LimitedK240950Disposable Prophy AnglePacific Care LimitedK240183Star E900 Handpiece SeriesDentalez, Inc., Stardental DivisionK230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

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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