Product Code: DZE


Total Product Life Cycle (TPLC) Devices

1101Implant, Endosseous, Root-formEndosseous Dental Implant.

FDA Consensus Standards

Implant, Endosseous, Root-Form [32309]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [35610]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [33850]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [33511]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [37849]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [31992]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [37372]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [35592]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [36822]21 CFR §872.3640 🔎
Implant, Endosseous, Root-Form [31733]21 CFR §872.3640 🔎

Pre-market Notifications for DZE

K192688S-Clean SQ-SL Implant System RegularDentis Co., Ltd.
K192347ST Internal Implant SystemMegagen Implant Co. Ltd
K192149MIS Dental Implant SystemDentsply Sirona Inc.
K192053W Zirconia ImplantsTAV Medical Ltd.
K191895Straumann Mini ImplantsInstitut Straumann AG
K191751EM ProvisionalHiossen, Inc.
K191256Straumann BLX Ø3.5 Mm ImplantsInstitut Straumann AG
K191201EM SA Implant SystemHiossen, Inc.
K191127Advanced Intermezzo Implant SystemMegaGen Implant Co., Ltd.
K191054Southern Implants MAX Implant SystemSouthern Implants (Pty) Ltd
K190958Neodent Implant SystemJJGC Industria E Comercio De Materiais Dentarios S.A.
K190849IS-III Active System_S-narrow TypeNeobiotech Co., Ltd.
K190837Internal Hex Implant SystemEBI Inc.
K190718Zygomatic ImplantsJJGC Industria E Comercio De Materiais Dentarios S.A.
K190662MRI Compatibility For Existing Straumann Dental Implant SystemsStraumann USA LLC

Global Unique Device Identification Database

00614950025442IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008872IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008575IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008568IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008551IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008544IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008537IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950008254IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007202IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007196IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007189IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007172IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007165IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007158IMPLANT, ENDOSSEOUS, ROOT-FORM
00614950007141IMPLANT, ENDOSSEOUS, ROOT-FORM

Maude Adverse Events

LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
INTERACTIVE IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
SIMPLY INTERACTIVE IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
SCREWPLANT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
DENTAL IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
SIMPLY INTERACTIVE IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
REPLANT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
DENTAL IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 4 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
REPLANT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
SCREWPLANT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 2 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
GODIRECT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 1 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
GODIRECT IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30
LEGACY 3 IMPLANTIMPLANT DIRECT SYBRON MANUFACTURING LLC2019-11-30

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