FDA.report

510(k) K904450

Device
BIOCERAM DENTAL IMPLANT, SERIES II
Applicant
KYOCERA AMERICA, INC.
510(k) number
K904450
Product code
DZE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-07-09
Date received
1990-09-28
Regulation
872.3640
Classification name
Implant, Endosseous, Root-form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Contact
KAZ HAYASHI
Address
8611 Balboa Ave. San Diego CA US 92123 92123

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DZE  

510(k)DeviceApplicantDecision date
K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB2026-05-12
K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.2026-03-23
K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.2026-03-16
K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG2026-03-10
K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.2026-03-04
K252197Nobel Biocare S Series ImplantsNobel Biocare AB2026-02-18
K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.2026-02-02
K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.2026-01-08
K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsParagon Implant Mfg., LLC2025-12-23
K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC2025-12-23
K251605DIMPLO Implant SystemDIMPLO, Ltd.2025-12-22
K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.2025-12-12
K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda2025-11-07
K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10

Legacy Summary

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FDA Review

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