Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2024949

FEI Number

2024949

Entity Name

DENTAMERICA

City/State/Country

City of Industry, CA, US

Establishment Address

18688 SAN JOSE AVE, City of Industry, CA 91748, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

DENTAMERICA (Owner Number: 2024949)

Owner / Operator Contact Address

18688 SAN JOSE AVE, City of Industry, CA 91748, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060640

PMA Number

N/A

All Registered Proprietary Names

APIXIA DIGIREX CAMMY EVERBRITE DENTAL BUR POLYBITE DENTAMERICA DENTAMERICA CELUX ENDO FILE LITEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2026-04-21
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2007-11-29
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2004-07-23
EJL	Bur, Dental	Dental	Class 1	872.3240	2015-11-12
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2001-12-04
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2010-09-27
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2001-12-04
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2010-02-04
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2010-09-27
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2001-12-04
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2012-07-10
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2015-11-12
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2001-12-04
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2010-09-27
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2007-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DENTAMERICA

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K831824	Silverman'S	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	1983-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.

Similar Registrations

Registration Number	Establishment Name	Location
3042046320	QPIX SOLUTIONS, INC.	Morrisville, NC, US
3020117925	ATHLOS OY	Espoo Uusimaa, FI
2032641	CYBER MEDICAL IMAGING, INC.	Los Angeles, CA, US
3004706313	VATECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2024949. Last updated year: 2026. Please use registration number 2024949 when referencing this establishment in official correspondence.