Interpore Imz Cylinder Implant System

Q: What is the product code of K913228?

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) K913228 · Interpore Intl.

Substantially Equivalent

510(k) numberK913228

Submission

Device name: Interpore Imz Cylinder Implant System
Applicant: Interpore Intl.
Irvine, CA, US
Received: July 22, 1991
Decision date: October 13, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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
K981253	Ultracon UltrafiltratorFJI · Traditional	12/11/1998SE
K980817	Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10…MQV · Traditional	09/25/1998SE
K972842	Interpore Inducer Bone Graft Delivery SyringeLYC · Traditional	10/30/1997SE
K971036	Odontit Autogenous Bone Collection DeviceGCY · Traditional	06/03/1997SE
K960945	Imz Membrane Tack SystemDZL · Traditional	05/24/1996SE
K960371	Interpore Threaded ImplantDZE · Traditional	03/08/1996SE
K955492	Interpore Imz Cyl Implant & Cyl Hex ImpltDZE · Traditional	01/30/1996SE
K952167	Imz Bone Tack SystemDZL · Traditional	11/21/1995SE
K950165	Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 to 1000…LYC · Traditional	03/28/1995SE
K922872	Interpore Cylindrical Hex Hydroxyapatite Coated Implant, 3.3 MM Diam.DZE · Traditional	07/25/1994SE

Questions and answers

When was Interpore Imz Cylinder Implant System cleared by the FDA?

Interpore Imz Cylinder Implant System (K913228) received a 510(k) decision of Substantially Equivalent on October 13, 1992, 449 days after the submission was received.

What is the product code of K913228?

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