Ultrasonic Surgery

FDA 510(k) K121620 · Dmetec.Co., Ltd.

Substantially Equivalent

510(k) numberK121620

Submission

Device name
Ultrasonic Surgery
Applicant
Dmetec.Co., Ltd.
Los Angeles, CA, US
Received
June 1, 2012
Decision date
December 11, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZI – Drill, Bone, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

Other 510(k)s with product code DZI

510(k)DeviceApplicantDecision
K253655Angled Screwdriver MED (M-SD090)DZI · Traditional W&H Dentalwerk Bürmoos GmbH07/31/2026SE
K253776Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional W&H Dentalwerk Buermoos GmbH06/18/2026SE
K254163VarioSurg 4DZI · Traditional Nakanishi, Inc.12/23/2025SE
K242432MT-BoneDZI · Traditional Mectron S.P.A.08/19/2024SE
K240340Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional Guangdong Jinme Medical Technology Co., Ltd.07/18/2024SE
K231087Guided Surgery KitDZI · Traditional Implant Direct Sybron Manufacturing, LLC08/16/2023SE
K192561Traus SUS20DZI · Traditional Saeshin Precision Co., Ltd.07/13/2020SE
K200265Surgical DrillsDZI · Traditional Implant Direct Sybron Manufacturing, LLC06/30/2020SE
K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional Bennett Jacoby, Dds, Ms, Inc.06/09/2020SE
K172137Piezotome CubeDZI · Traditional Satelec - Acteon Group05/03/2018SE

More from Satelec - Acteon Group

510(k)DeviceDecision
K170104Compact S, Compact S (LED)ELC · Traditional 12/27/2017SE
K113152Ultrasonic Surgery MachineDZI · Traditional 06/14/2012SE
K060171Cleanse S+ Ultrasonic ScalerELC · Traditional 03/29/2006SE
K051571Skylight LED Curing LightEBZ · Traditional 07/19/2005SE

Questions and answers

When was Ultrasonic Surgery cleared by the FDA?

Ultrasonic Surgery (K121620) received a 510(k) decision of Substantially Equivalent on December 11, 2012, 193 days after the submission was received.

What is the product code of K121620?

The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.