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FDA 510(k)

CERAPEARL

K-Number: K854763 · 1986-02-21

ApplicantKyocera International, Inc.
Decision Date1986-02-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAPEARL 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 1986-02-21 under 510(k) number K854763. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERAPEARL?

CERAPEARL is a medical device that received FDA 510(k) clearance on 1986-02-21. The listed applicant is Kyocera International, Inc.. The 510(k) number is K854763.

When did CERAPEARL receive FDA 510(k) clearance?

CERAPEARL received FDA 510(k) clearance on 1986-02-21, under 510(k) number K854763.

Who is the listed applicant for CERAPEARL?

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 CERAPEARL?

The FDA product code for CERAPEARL is EIH.

Related Clinical Trials

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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 IMPLANTK760008DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL

Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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