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FDA 510(k)

KYOCERA BIOCERAM POROUS DENTAL IMPLANT

K-Number: K860360 · 1986-04-04

ApplicantKyocera International, Inc.
Decision Date1986-04-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KYOCERA BIOCERAM POROUS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Kyocera International, Inc.. It received FDA 510(k) clearance on 1986-04-04 under 510(k) number K860360. 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 KYOCERA BIOCERAM POROUS DENTAL IMPLANT?

KYOCERA BIOCERAM POROUS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1986-04-04. The listed applicant is Kyocera International, Inc.. The 510(k) number is K860360.

When did KYOCERA BIOCERAM POROUS DENTAL IMPLANT receive FDA 510(k) clearance?

KYOCERA BIOCERAM POROUS DENTAL IMPLANT received FDA 510(k) clearance on 1986-04-04, under 510(k) number K860360.

Who is the listed applicant for KYOCERA BIOCERAM POROUS DENTAL IMPLANT?

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

What is the FDA product code for KYOCERA BIOCERAM POROUS DENTAL IMPLANT?

The FDA product code for KYOCERA BIOCERAM POROUS DENTAL IMPLANT is DZE.

Related Clinical Trials

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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Other records listing Kyocera International, Inc. as applicant

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.

K854763CERAPEARLK760008DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL

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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