Product Code: DZE

Total Product Life Cycle (TPLC) Devices

1101

Implant, Endosseous, Root-form

Endosseous 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

K222497	Zaga Zygomatic System	Southern Implants (Pty) Ltd
K222231	S.I.N. Dental Implant System	S.I.N. - Sistema De Implante Nacional S.A.
K221094	OmniTaper EV Dental Implants, DS Implants Abutments With EV Connection	Dentsply Sirona
K220978	TSX Implants	Biomet 3i LLC
K220841	PrimeTaper EV Dental Implants Ø3.0, DS Implants Abutments With EV Connection (XS)	Dentsply Sirona
K220517	IBS System	InnoBioSurg Co., Ltd.
K220251	Neodent Implant System - GM Narrow Implant System	JJGC Industria E Comercio De Materiais Dentarios S.A.
K220200	Paltop Conical Implant System	Paltop Advanced Dental Solutions, Ltd
K213997	Kontact Dental Implant System	Biotech Dental, SAS
K213672	T3 Pro Implants	Biomet 3i LLC
K213599	SuperLine	Dentium Co., Ltd.
K213576	Tatum Surgical Dental Implant System	Suncoast Dental, Inc. Dba Tatum Surgical
K213506	NB 1 SA Implant System	Arumdentistry Co., Ltd.
K212775	Adin Short Implants	Adin Dental Implants Systems Ltd.
K212785	Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK Temporary Abutments	Blue Sky Bio, LLC

Global Unique Device Identification Database

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

Maude Adverse Events

NOBELACTIVE INTERNAL RP 5.0X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELREPLACE CC NP 3.5X13MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE 3.0 3.0X11.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X11.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X7MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X11.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL NP 3.5X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELSPEEDY GROOVY RP 4X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELREPLACE CC NP 3.5X13MM	NOBEL BIOCARE AB	2020-03-31
BR?NEMARK SYSTEM MK III GROOVY WP 5X10MM	NOBEL BIOCARE AB	2020-03-31
BR?NEMARK SYSTEM MK III GROOVY WP 5X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 5.0X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X15MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELSPEEDY GROOVY RP 5.0X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE 3.0 3.0X11.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X15MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL NP 3.5X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X7MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X7MM	NOBEL BIOCARE AB	2020-03-31
UNKNOWN ? IMPLANT	NOBEL BIOCARE AB	2020-03-31
NOBELSPEEDY GROOVY RP 5.0X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELSPEEDY GROOVY RP 4X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC NP 3.75X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X15MM	NOBEL BIOCARE AB	2020-03-31
UNKNOWN ? IMPLANT	NOBEL BIOCARE AB	2020-03-31
NOBELREPLACE CC PMC RP 4.3X8MM	NOBEL BIOCARE USA INC	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X15MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X8.5MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELACTIVE INTERNAL RP 5.0X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELSPEEDY GROOVY RP 4X10MM	NOBEL BIOCARE AB	2020-03-31
NOBELPARALLEL CC RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
REPLACE SELECT TAPERED PMC RP 4.3X11.5MM	NOBEL BIOCARE USA INC	2020-03-31
NOBELPARALLEL CC RP 4.3X7MM	NOBEL BIOCARE AB	2020-03-31
UNKNOWN ? IMPLANT	NOBEL BIOCARE AB	2020-03-31
UNKNOWN ? IMPLANT	NOBEL BIOCARE AB	2020-03-31
NOBELREPLACE CC RP 4.3X13MM	NOBEL BIOCARE USA INC	2020-03-31
NOBELPARALLEL CC RP 4.3X10MM	NOBEL BIOCARE AB	2020-03-31
REPLACE SELECT TAPERED PMC RP 4.3X11.5MM	NOBEL BIOCARE USA INC	2020-03-31