Endosseous Implants

FDA 510(k) K924219 · The Stern Metals Co., Inc.

Substantially Equivalent

510(k) numberK924219

Submission

Device name
Endosseous Implants
Applicant
The Stern Metals Co., Inc.
Attleboro, MA, US
Received
August 21, 1992
Decision date
February 14, 1994
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)DeviceApplicantDecision
K260463ZEROS Dental Implant SystemDZE · Special Zeros Co., Ltd.08/19/2026SE
K251188UNIQA® Dental Implants SystemDZE · Traditional Uniqa Dental, Ltd.06/25/2026SE
K251232MegaGen Zygoma Dental Implant SystemDZE · Traditional Megagen Implant Co., Ltd.06/18/2026SE
K250806Dental Implant SystemDZE · Traditional A.B. Dental Devices , Ltd.06/18/2026SE
K260006INOSS SystemDZE · Traditional Inosys, Inc.06/17/2026SE
K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional Promimic AB05/12/2026SE
K252031Adin Long Dental Implant SystemDZE · Traditional Adin Dental Implant Systems , Ltd.03/23/2026SE
K253334ZENEX Implant System_Short (R-System)DZE · Traditional Izenimplant Co., Ltd.03/16/2026SE
K252168Straumann® BLC Implants - Indication WideningDZE · Traditional Institut Straumann AG03/10/2026SE
K253493Dentis SQ-SL AXEL FixtureDZE · Traditional Dentis Co., Ltd.03/04/2026SE

More from Dentis Co., Ltd.

510(k)DeviceDecision
K962301Sterngold G-Hard Metal AlloyEJS · Traditional 07/18/1996SE
K933193Impla-Med Ucla Type Abutments,Screwdriver,Reamer,LDZE · Traditional 03/07/1994SE
K926305Impla-Med Hex Screw Implants: 4,5 & 6MM DiameterDZE · Traditional 03/01/1994SE

Questions and answers

When was Endosseous Implants cleared by the FDA?

Endosseous Implants (K924219) received a 510(k) decision of Substantially Equivalent on February 14, 1994, 542 days after the submission was received.

What is the product code of K924219?

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