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FDA 510(k)

PROTECH DENT

K-Number: K121272 · 2012-10-15

ApplicantAkervall Technologies, Inc.
Decision Date2012-10-15
Product CodeOBR
DecisionSubstantially Equivalent

Device Summary

PROTECH DENT is the device name listed in this FDA 510(k) record. The listed applicant is Akervall Technologies, Inc.. It received FDA 510(k) clearance on 2012-10-15 under 510(k) number K121272. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECH DENT?

PROTECH DENT is a medical device that received FDA 510(k) clearance on 2012-10-15. The listed applicant is Akervall Technologies, Inc.. The 510(k) number is K121272.

When did PROTECH DENT receive FDA 510(k) clearance?

PROTECH DENT received FDA 510(k) clearance on 2012-10-15, under 510(k) number K121272.

Who is the listed applicant for PROTECH DENT?

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

What is the FDA product code for PROTECH DENT?

The FDA product code for PROTECH DENT is OBR. This falls under the Orthopedic category.

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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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