NDX Paramount Dental Laboratory

FDA Device Registration & Listing · Sacramento, CA, US · Registration 3012690648

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012690648
FEI Number
3012690648
Entity Name
NDX Paramount Dental Laboratory
City/State/Country
Sacramento, CA, US
Establishment Address
1851 Heritage Lane, Ste 148, Sacramento, CA 95815, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
National Dentex LLC (Owner Number: 9052467)
Owner / Operator Contact Address
4400 PGA Blvd, Suite 700, Palm Beach Gardens, FL 33410, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K242340
PMA Number
N/A

All Registered Proprietary Names

DESS Ti Base Abutments Restoration, porcelain DESS Ti Base Abutments Restoration, noble metal DESS Ti Base Abutments DESS Ti Base Abutments Dentures, partial Restoration, porcelain-fused-to-metal DESS Ti Base Abutments Restoration, base metal DESS Ti Base Abutments Dentures, full Restoration, resin, crown and bridge Prosthesis, orthodontic DESS Ti Base Abutments DESS Ti Base Abutments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NSP Restoration, Porcelain Unknown Class N N/A 2008-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NSJ Restoration, Noble Metal Unknown Class N N/A 2008-02-01
PNP Dental Abutment Design Software For Dental Laboratory Dental Class 2 872.3630 2026-02-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NSK Dentures, Partial Unknown Class N N/A 2008-02-01
NSO Restoration, Porcelain-Fused-To-Metal Unknown Class N N/A 2008-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NSQ Restoration, Base Metal Unknown Class N N/A 2008-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NSL Dentures, Full Unknown Class N N/A 2008-02-01
NSN Restoration, Resin, Crown And Bridge Unknown Class N N/A 2008-02-01
NSR Prosthesis, Orthodontic Unknown Class N N/A 2008-02-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2026-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

National Dentex LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010138699 NDX nSequence Reno, NV, US
3004755100 ALBENSI DENTAL LAB Irwin, PA, US
3002916277 GREEN DENTAL LAB Heber Springs, AR, US
3006650414 KELLER LABORATORIES Fenton, MO, US
3005512166 NELSON DENTAL LAB Rochester Hills, MI, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012690648. Last updated year: 2026. Please use registration number 3012690648 when referencing this establishment in official correspondence.
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