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510(k) K242217

Device
Surcam Dental Implant System
Applicant
Surcam Medical Devices and Developments, Ltd.
510(k) number
K242217
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-29
Date received
2024-07-29
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shay Shabat
Address
1 Hayotzrim Nahariya IL 2231101 2231101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZE#

510(k), Device, Applicant table
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K251938GEN5 and GEN5+ Dental Implant SystemParagon Implant Mfg., LLC2025-10-30
K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10