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FDA 510(k)

DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL

K-Number: K760008 · 1976-10-05

ApplicantKyocera International, Inc.
Decision Date1976-10-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL 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 1976-10-05 under 510(k) number K760008. 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 DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL?

DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL is a medical device that received FDA 510(k) clearance on 1976-10-05. The listed applicant is Kyocera International, Inc.. The 510(k) number is K760008.

When did DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL receive FDA 510(k) clearance?

DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL received FDA 510(k) clearance on 1976-10-05, under 510(k) number K760008.

Who is the listed applicant for DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL?

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 DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL?

The FDA product code for DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL 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.

K860360KYOCERA BIOCERAM POROUS DENTAL IMPLANTK854763CERAPEARL

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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