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FDA 510(k)

BIOPLANT

K-Number: K050984 · 2005-08-11

ApplicantKerr Dental Materials Center
Decision Date2005-08-11
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 2005-08-11 under 510(k) number K050984. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLANT?

BIOPLANT is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K050984.

When did BIOPLANT receive FDA 510(k) clearance?

BIOPLANT received FDA 510(k) clearance on 2005-08-11, under 510(k) number K050984.

Who is the listed applicant for BIOPLANT?

The FDA 510(k) record lists Kerr Dental Materials Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPLANT?

The FDA product code for BIOPLANT is LYC.

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Related Devices (Code: LYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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