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FDA 510(k)

BIOCERAM DENTAL IMPLANT, SERIES II

K-Number: K904450 · 1991-07-09

ApplicantKyocera America, Inc.
Decision Date1991-07-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOCERAM DENTAL IMPLANT, SERIES II is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera America, Inc.. It received FDA 510(k) clearance on 1991-07-09 under 510(k) number K904450. 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 BIOCERAM DENTAL IMPLANT, SERIES II?

BIOCERAM DENTAL IMPLANT, SERIES II is a medical device that received FDA 510(k) clearance on 1991-07-09. The listed applicant is Kyocera America, Inc.. The 510(k) number is K904450.

When did BIOCERAM DENTAL IMPLANT, SERIES II receive FDA 510(k) clearance?

BIOCERAM DENTAL IMPLANT, SERIES II received FDA 510(k) clearance on 1991-07-09, under 510(k) number K904450.

Who is the listed applicant for BIOCERAM DENTAL IMPLANT, SERIES II?

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

What is the FDA product code for BIOCERAM DENTAL IMPLANT, SERIES II?

The FDA product code for BIOCERAM DENTAL IMPLANT, SERIES II is DZE.

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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