Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1049061

FEI Number

1049061

Entity Name

DENTALEZ OF ALABAMA

City/State/Country

BAY MINETTE, AL, US

Establishment Address

2500 U.S. HIGHWAY 31 SOUTH, BAY MINETTE, AL 36507, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DENTALEZ, INC. (Owner Number: 2513147)

Owner / Operator Contact Address

301 Lindenwood Drive, Suite 100, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NuSimplicity Chair CORE Chair CORE Light Simplicity Light Simplicity LED Light CORE Delivery Unit Galaxy Delivery Unit Ramvac 3 Compressor Ramvac Tanks 30 Gallon Tank Ramvac 7 Dry Vacuum System (Bison 5) Ramvac 12 Dry Vacuum System (Bison 9) Ramvac 5 Dry Vacuum System (Bison 3) Ramvac 4 Dry Vacuum System (Bulldog QT 2) Barracuda MC-202 Ramvac 12 Compressor Ramvac Tanks 15 Gallon Tank Ramvac 5 Compressor Ramvac Tanks Infini Tank Ramvac 18 Compressor Ramvac 5 Compressor w/Sound Shield NXT Hg5 Amalgam Separator Barracuda MC-201 Ramvac Badger LF Dry Vacuum Ramvac 10 Dry Vacuum System (Bison 7) Ramvac 8 Compressor NXT Hg5 High Volume Amalgam Separator Ramvac Tanks 50 Gallon Cylindrical Tank Barracuda CV-102 Ramvac 3 Compressor w/Sound Shield NXT Hg5 MINI Amalagam Separator Barracuda CV-101

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2008-01-18
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	1992-09-30
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2008-01-21
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2019-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTALEZ, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1049061. Last updated year: 2026. Please use registration number 1049061 when referencing this establishment in official correspondence.