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

K222497Zaga Zygomatic SystemSouthern Implants (Pty) Ltd
K222231S.I.N. Dental Implant SystemS.I.N. - Sistema De Implante Nacional S.A.
K221094OmniTaper EV Dental Implants, DS Implants Abutments With EV ConnectionDentsply Sirona
K220978TSX ImplantsBiomet 3i LLC
K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants Abutments With EV Connection (XS)Dentsply Sirona
K220517IBS SystemInnoBioSurg Co., Ltd.
K220251Neodent Implant System - GM Narrow Implant SystemJJGC Industria E Comercio De Materiais Dentarios S.A.
K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd
K213997Kontact Dental Implant SystemBiotech Dental, SAS
K213672T3 Pro ImplantsBiomet 3i LLC
K213599SuperLineDentium Co., Ltd.
K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical
K213506NB 1 SA Implant SystemArumdentistry Co., Ltd.
K212775Adin Short ImplantsAdin Dental Implants Systems Ltd.
K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK Temporary AbutmentsBlue Sky Bio, 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

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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