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FDA 510(k)

PERFECT TISSUE CONTOURING SYSTEM II

K-Number: K071632 · 2007-10-18

ApplicantColtene/Whaledent, Inc.
Decision Date2007-10-18
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFECT TISSUE CONTOURING SYSTEM II 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 2007-10-18 under 510(k) number K071632. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFECT TISSUE CONTOURING SYSTEM II?

PERFECT TISSUE CONTOURING SYSTEM II is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K071632.

When did PERFECT TISSUE CONTOURING SYSTEM II receive FDA 510(k) clearance?

PERFECT TISSUE CONTOURING SYSTEM II received FDA 510(k) clearance on 2007-10-18, under 510(k) number K071632.

Who is the listed applicant for PERFECT TISSUE CONTOURING SYSTEM II?

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 PERFECT TISSUE CONTOURING SYSTEM II?

The FDA product code for PERFECT TISSUE CONTOURING SYSTEM II is EKZ.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: EKZ)

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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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