FDA.reportPublic FDA data

510(k) K251938

Device
GEN5 and GEN5+ Dental Implant System
Applicant
Paragon Implant Mfg., LLC
510(k) number
K251938
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-30
Date received
2025-06-24
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
Renee Bennett
Address
27030 Malibu Hills Rd. Calabasas CA US 91301 91301

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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K243078HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc.2025-10-10
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