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FDA 510(k)

INNO SLA SUBMERGED IMPLANT SYSTEM

K-Number: K132242 · 2013-12-06

ApplicantCowellmedi Co., Ltd.
Decision Date2013-12-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INNO SLA SUBMERGED IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cowellmedi Co., Ltd.. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K132242. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INNO SLA SUBMERGED IMPLANT SYSTEM?

INNO SLA SUBMERGED IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Cowellmedi Co., Ltd.. The 510(k) number is K132242.

When did INNO SLA SUBMERGED IMPLANT SYSTEM receive FDA 510(k) clearance?

INNO SLA SUBMERGED IMPLANT SYSTEM received FDA 510(k) clearance on 2013-12-06, under 510(k) number K132242.

Who is the listed applicant for INNO SLA SUBMERGED IMPLANT SYSTEM?

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

What is the FDA product code for INNO SLA SUBMERGED IMPLANT SYSTEM?

The FDA product code for INNO SLA SUBMERGED IMPLANT SYSTEM is DZE.

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Other records listing Cowellmedi Co., Ltd. as applicant

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Related Devices (Code: DZE)

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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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