Abutment Selection Kit

Q: What is the product code of K960639?

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) K960639 · Nobelpharma USA, Inc.

Substantially Equivalent

510(k) numberK960639

Submission

Device name: Abutment Selection Kit
Applicant: Nobelpharma USA, Inc.
Westmont, IL, US
Received: February 14, 1996
Decision date: May 14, 1996
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
K984162	Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseMAH · Traditional	06/28/1999SE
K962403	Noblepharma Wide AccessoriesDZE · Traditional	09/06/1996SE
K955713	Nobelpharma Bone Anchored Hearing AidLXB · Traditional	08/09/1996SE
K962130	Branemark Systems Mkii Selk-Tapping FixtureDZE · Traditional	07/22/1996SE
K961736	17 Angulated AbutmentNHA · Traditional	07/18/1996SE
K961737	Cera One Abutment SystemDZE · Traditional	07/10/1996SE
K961728	Miruscone Abutment SystemNHA · Traditional	07/10/1996SE
K955697	Abutment Retrieval KitDZE · Traditional	01/30/1996SE
K955372	Ball Attachment SystemDZE · Traditional	01/23/1996SE
K953435	Branemark Radiographic Depth GuageDZE · Traditional	10/03/1995SE

Questions and answers

When was Abutment Selection Kit cleared by the FDA?

Abutment Selection Kit (K960639) received a 510(k) decision of Substantially Equivalent on May 14, 1996, 90 days after the submission was received.

What is the product code of K960639?

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