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

K212517Magicore SystemInnoBioSurg Co., Ltd.
K212125Nobel Biocare Dental Implant Systems Portfolio - MR ConditionalNobel Biocare AG
K211052Straumann RidgeFit ImplantsInstitut Straumann AG
K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona
K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.
K210523ImplanovaDental Evolutions Inc.
K210336Neodent Implant System - Zirconia Implant SystemJJGC Industria E Comercio De Materiais Dentarios SA
K210220Kontact Dental Implant SystemBIOTECH DENTAL, SAS
K210161AnyOne Onestage Implant SystemMegaGen Implant Co., Ltd.
K210132S-Clean SQ-SL Implant System RegularDentis Co., Ltd.
K210080Dentis S-Clean S-Line MiniDentis Co., Ltd.
K203725S.I.N. Dental Implant SystemS.I.N.- Sistema De Implante Nacional S.A.
K203701Locator Overdenture Implant SystemIvory Super Holdco Inc. / Zest Anchors LLC
K203554AnyOne External Implant SystemMegaGen Implant Co., Ltd.
K203382Neodent Implant System-Easy PackJJGC Industria E Comercio De Materiais Dentarios S.A.

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

NOBELACTIVE INTERNAL RP 5.0X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X10MMNOBEL BIOCARE AB2020-03-31
NOBELREPLACE CC NP 3.5X13MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE 3.0 3.0X11.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X11.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X7MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X11.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL NP 3.5X10MMNOBEL BIOCARE AB2020-03-31
NOBELSPEEDY GROOVY RP 4X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 4.3X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELREPLACE CC NP 3.5X13MMNOBEL BIOCARE AB2020-03-31
BR?NEMARK SYSTEM MK III GROOVY WP 5X10MMNOBEL BIOCARE AB2020-03-31
BR?NEMARK SYSTEM MK III GROOVY WP 5X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 5.0X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X15MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 4.3X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELSPEEDY GROOVY RP 5.0X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE 3.0 3.0X11.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 4.3X15MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL NP 3.5X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X7MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X7MMNOBEL BIOCARE AB2020-03-31
UNKNOWN ? IMPLANTNOBEL BIOCARE AB2020-03-31
NOBELSPEEDY GROOVY RP 5.0X10MMNOBEL BIOCARE AB2020-03-31
NOBELSPEEDY GROOVY RP 4X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC NP 3.75X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X15MMNOBEL BIOCARE AB2020-03-31
UNKNOWN ? IMPLANTNOBEL BIOCARE AB2020-03-31
NOBELREPLACE CC PMC RP 4.3X8MMNOBEL BIOCARE USA INC2020-03-31
NOBELACTIVE INTERNAL RP 4.3X15MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X8.5MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
NOBELACTIVE INTERNAL RP 5.0X10MMNOBEL BIOCARE AB2020-03-31
NOBELSPEEDY GROOVY RP 4X10MMNOBEL BIOCARE AB2020-03-31
NOBELPARALLEL CC RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
REPLACE SELECT TAPERED PMC RP 4.3X11.5MMNOBEL BIOCARE USA INC2020-03-31
NOBELPARALLEL CC RP 4.3X7MMNOBEL BIOCARE AB2020-03-31
UNKNOWN ? IMPLANTNOBEL BIOCARE AB2020-03-31
UNKNOWN ? IMPLANTNOBEL BIOCARE AB2020-03-31
NOBELREPLACE CC RP 4.3X13MMNOBEL BIOCARE USA INC2020-03-31
NOBELPARALLEL CC RP 4.3X10MMNOBEL BIOCARE AB2020-03-31
REPLACE SELECT TAPERED PMC RP 4.3X11.5MMNOBEL BIOCARE USA INC2020-03-31

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