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PARAGON IMPLANT MFG., LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054098993005409899PARAGON IMPLANT MFG., LLC1N2027-01-0127030 Malibu Hills Rd Calabasas CA US 91301

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810157313867TriActive Implant - TriActive Imp. 3.2mmD-8.5mmL-3.0mmP1-855-649-4365info@paragon-implant.com
00810157314048TriActive Implant - TriActive Imp. 3.2mmD-10mmL-3.0mmP1-855-649-4365info@paragon-implant.com
00810157314161TriActive Implant - TriActive Imp. 3.2mmD-11.5mmL-3.0mmP1-855-649-4365info@paragon-implant.com
00810157314208TriActive Implant - TriActive Imp. 3.2mmD-13mmL-3.0mmP1-855-649-4365info@paragon-implant.com
00810157314536TriActive Implant - TriActive Imp. 3.2mmD-15mmL-3.0mmP1-855-649-4365info@paragon-implant.com
00810157314543TriActive Implant - TriActive Imp. 3.7mmD-7mmL-3.4mmP1-855-649-4365info@paragon-implant.com
00810157315724Friction-Fit Removal Tool - Friction Fit Removal Tool, M1.61-855-649-4365info@paragon-implant.com
00810157315731Friction-Fit Removal Tool - Friction Fit Removal Tool, M2.01-855-649-4365info@paragon-implant.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3314891746858411K261392TriActive Dental Implant SystemDZE2026-09-17
3314891036565517K252145GEN5™ and GEN5+™ 3.3mmD Dental ImplantsDZE2025-12-23
3314891714135322K251938GEN5 and GEN5+ Dental Implant SystemDZE2025-10-30
3314891666229434K251756Sterilization TraysKCT2025-11-14
3314892053138823K250476NizPlant Dental Implant SystemDZE2025-12-23
3314891091487878
3314891186738833

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE42026-09-17
KCT12025-11-14

PMN#

GUDID#

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