Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1

Q: What is the product code of K101225?

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) K101225 · Promimic AB

Substantially Equivalent

510(k) numberK101225

Submission

Device name: Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1
Applicant: Promimic AB
Goteborg, SE
Received: May 3, 2010
Decision date: January 25, 2011
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

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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
K252731	Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional	05/12/2026SE

Questions and answers

When was Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1 cleared by the FDA?

Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant, 3.75 MM, Length 10 MM Model 03-1 (K101225) received a 510(k) decision of Substantially Equivalent on January 25, 2011, 267 days after the submission was received.

What is the product code of K101225?

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