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FDA 510(k)

PROANGLE DISPOSABLE PROPHY ANGLE

K-Number: K030603 · 2003-04-14

ApplicantPac-Dent International (Suzhou), Ltd.
Decision Date2003-04-14
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROANGLE DISPOSABLE PROPHY ANGLE is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International (Suzhou), Ltd.. It received FDA 510(k) clearance on 2003-04-14 under 510(k) number K030603. 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 PROANGLE DISPOSABLE PROPHY ANGLE?

PROANGLE DISPOSABLE PROPHY ANGLE is a medical device that received FDA 510(k) clearance on 2003-04-14. The listed applicant is Pac-Dent International (Suzhou), Ltd.. The 510(k) number is K030603.

When did PROANGLE DISPOSABLE PROPHY ANGLE receive FDA 510(k) clearance?

PROANGLE DISPOSABLE PROPHY ANGLE received FDA 510(k) clearance on 2003-04-14, under 510(k) number K030603.

Who is the listed applicant for PROANGLE DISPOSABLE PROPHY ANGLE?

The FDA 510(k) record lists Pac-Dent International (Suzhou), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROANGLE DISPOSABLE PROPHY ANGLE?

The FDA product code for PROANGLE DISPOSABLE PROPHY ANGLE is EGS.

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Other records listing Pac-Dent International (Suzhou), Ltd. as applicant

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Related Devices (Code: EGS)

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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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