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FDA 510(k)

INCLUSIVE MINI IMPLANT

K-Number: K100932 · 2010-12-27

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2010-12-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INCLUSIVE MINI IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K100932. 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 INCLUSIVE MINI IMPLANT?

INCLUSIVE MINI IMPLANT is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K100932.

When did INCLUSIVE MINI IMPLANT receive FDA 510(k) clearance?

INCLUSIVE MINI IMPLANT received FDA 510(k) clearance on 2010-12-27, under 510(k) number K100932.

Who is the listed applicant for INCLUSIVE MINI IMPLANT?

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

What is the FDA product code for INCLUSIVE MINI IMPLANT?

The FDA product code for INCLUSIVE MINI IMPLANT is DZE.

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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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