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510(k) K250476

Device
NizPlant Dental Implant System
Applicant
Paragon Implant Mfg., LLC
510(k) number
K250476
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-23
Date received
2025-02-19
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Abbreviated
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

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