Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005512166

FEI Number

3005512166

Entity Name

NELSON DENTAL LAB

City/State/Country

Rochester Hills, MI, US

Establishment Address

1654 Star Batt Dr, Rochester Hills, MI 48309, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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

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
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
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
PNP	Dental Abutment Design Software For Dental Laboratory	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
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
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
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2008-02-01
NSL	Dentures, Full	Unknown	Class N	N/A	2008-02-01

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
3012690648	NDX Paramount Dental Laboratory	Sacramento, CA, 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.

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005512166. Last updated year: 2026. Please use registration number 3005512166 when referencing this establishment in official correspondence.