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FDA 510(k)

LUTEMOLL (BIOPLAST)

K-Number: K871038 · 1987-05-19

ApplicantB. L. Dental Co.
Decision Date1987-05-19
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LUTEMOLL (BIOPLAST) is the device name listed in this FDA 510(k) record. The listed applicant is B. L. Dental Co.. It received FDA 510(k) clearance on 1987-05-19 under 510(k) number K871038. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUTEMOLL (BIOPLAST)?

LUTEMOLL (BIOPLAST) is a medical device that received FDA 510(k) clearance on 1987-05-19. The listed applicant is B. L. Dental Co.. The 510(k) number is K871038.

When did LUTEMOLL (BIOPLAST) receive FDA 510(k) clearance?

LUTEMOLL (BIOPLAST) received FDA 510(k) clearance on 1987-05-19, under 510(k) number K871038.

Who is the listed applicant for LUTEMOLL (BIOPLAST)?

The FDA 510(k) record lists B. L. Dental Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUTEMOLL (BIOPLAST)?

The FDA product code for LUTEMOLL (BIOPLAST) is EBI.

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Related Devices (Code: EBI)

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

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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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