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FDA 510(k)

COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC

K-Number: K912485 · 1991-07-25

ApplicantColtene/Whaledent, Inc.
Decision Date1991-07-25
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1991-07-25 under 510(k) number K912485. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC?

COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K912485.

When did COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC receive FDA 510(k) clearance?

COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC received FDA 510(k) clearance on 1991-07-25, under 510(k) number K912485.

Who is the listed applicant for COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC?

The FDA product code for COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC is ELW.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: ELW)

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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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