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510(k) K231087

Device
Guided Surgery Kit
Applicant
Implant Direct Sybron Manufacturing, LLC
510(k) number
K231087
Product code
DZI
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-16
Date received
2023-04-17
Regulation
872.4120
Classification name
Drill, Bone, Powered
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Reina Choi
Address
3050 E Hillcrest Dr. Thousand Oaks CA US 91362 91362

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254163VarioSurg 4Nakanishi, Inc.2025-12-23
K242432MT-BoneMectron S.P.A.2024-08-19
K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.2024-07-18
K192561TRAUS SUS20Saeshin Precision Co., Ltd.2020-07-13
K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC2020-06-30
K192033Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad TipBennett Jacoby, Dds, Ms, Inc.2020-06-09
K172137PIEZOTOME CUBESatelec - Acteon Group2018-05-03
K171326Piezosurgery WhiteMectron S.P.A.2018-04-13
K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A.2018-01-12
K152125Oral Surgery System and AccessoriesBonart Co., Ltd.2016-08-15
K151248PIEZOSURGERY WHITEMectron S.P.A.2015-09-04
K151171TRAUS SUS10Saeshin Precision Co., Ltd.2015-09-01
K150076Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800LDong IL Technology , Ltd.2015-06-02
K133488PIEZOMEDW&H Dentalwerk Buermoos GmbH2014-10-16
K121620ULTRASONIC SURGERYDmetec.Co., Ltd.2012-12-11