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FDA 510(k)

BK BLANK MODEL 20,40,65,90

K-Number: K101875 · 2010-08-23

ApplicantBk Medent Co., Ltd.
Decision Date2010-08-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BK BLANK MODEL 20,40,65,90 is the device name listed in this FDA 510(k) record. The listed applicant is Bk Medent Co., Ltd.. It received FDA 510(k) clearance on 2010-08-23 under 510(k) number K101875. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BK BLANK MODEL 20,40,65,90?

BK BLANK MODEL 20,40,65,90 is a medical device that received FDA 510(k) clearance on 2010-08-23. The listed applicant is Bk Medent Co., Ltd.. The 510(k) number is K101875.

When did BK BLANK MODEL 20,40,65,90 receive FDA 510(k) clearance?

BK BLANK MODEL 20,40,65,90 received FDA 510(k) clearance on 2010-08-23, under 510(k) number K101875.

Who is the listed applicant for BK BLANK MODEL 20,40,65,90?

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

What is the FDA product code for BK BLANK MODEL 20,40,65,90?

The FDA product code for BK BLANK MODEL 20,40,65,90 is EIH.

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Related Devices (Code: EIH)

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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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