Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts

Q: What is the product code of K192221?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.

FDA 510(k) K192221 · Implant Direct Sybron Manufacturing, LLC

Substantially Equivalent

510(k) numberK192221

Submission

Device name: Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
Applicant: Implant Direct Sybron Manufacturing, LLC
Thousand Oaks, CA, US
Received: August 15, 2019
Decision date: June 25, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DZE – Implant, Endosseous, Root-Form
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3640
Specialty: Dental
Implant: Yes

Other 510(k)s with product code DZE

510(k)	Device	Applicant	Decision
K260463	ZEROS Dental Implant SystemDZE · Special	Zeros Co., Ltd.	08/19/2026SE
K251188	UNIQA® Dental Implants SystemDZE · Traditional	Uniqa Dental, Ltd.	06/25/2026SE
K251232	MegaGen Zygoma Dental Implant SystemDZE · Traditional	Megagen Implant Co., Ltd.	06/18/2026SE
K250806	Dental Implant SystemDZE · Traditional	A.B. Dental Devices , Ltd.	06/18/2026SE
K260006	INOSS SystemDZE · Traditional	Inosys, Inc.	06/17/2026SE
K252731	Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional	Promimic AB	05/12/2026SE
K252031	Adin Long Dental Implant SystemDZE · Traditional	Adin Dental Implant Systems , Ltd.	03/23/2026SE
K253334	ZENEX Implant System_Short (R-System)DZE · Traditional	Izenimplant Co., Ltd.	03/16/2026SE
K252168	Straumann® BLC Implants - Indication WideningDZE · Traditional	Institut Straumann AG	03/10/2026SE
K253493	Dentis SQ-SL AXEL FixtureDZE · Traditional	Dentis Co., Ltd.	03/04/2026SE

More from Dentis Co., Ltd.

510(k)	Device	Decision
K231087	Guided Surgery KitDZI · Traditional	08/16/2023SE
K223535	SMARTbase Abutment SystemNHA · Traditional	06/20/2023SE
K222211	Implant Direct Dental Implant Systems Portfolio - MR ConditionalDZE · Traditional	02/02/2023SE
K202524	Standard Sterilizable TrayKCT · Traditional	01/28/2021SE
K201553	Simply Iconic ImplantsDZE · Traditional	01/22/2021SE
K200858	Mini Sterilizable TrayKCT · Traditional	08/06/2020SE
K200265	Surgical DrillsDZI · Traditional	06/30/2020SE
K192218	Custom Legacy and Custom InterActive Titanium AbutmentsNHA · Traditional	05/08/2020SE
K191458	Legacy SMARTBase AbutmentsNHA · Traditional	10/10/2019SE
K181359	InterActive SMARTBase AbutmentsNHA · Traditional	08/15/2018SE

Questions and answers

When was Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts cleared by the FDA?

Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (K192221) received a 510(k) decision of Substantially Equivalent on June 25, 2020, 315 days after the submission was received.

What is the product code of K192221?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.