FDA.reportPublic FDA data

APOZA

Primary DI
04719883751522
Brand
APOZA
Company
APOZA ENTERPRISE CO., LTD.
Model
CAM-I
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719883751522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883751522047198837515224719883751522

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral cameraAn electro-optical device designed for image and/or video capture of the teeth and other intraoral anatomy, to assist with the diagnosis/management of dental/intraoral conditions (e.g., caries, plaque, calculus). It may be provided with specialized camera heads for specific types of examination (e.g., acquiring high resolution pictures/videos, emitting violet or infrared light), as well as camera holders and cables; it connects to an off-the-shelf computer (not included) for the power/processing/display.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656816337
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719883751539APOZAOzonyMED2023-06-28
04719883750822APOZAOzone DTA2023-06-26
04719883751379APOZALED TURBO2023-06-28
04719883751386APOZASelector U2 Plus2023-06-28
04719883751393APOZASelector U2 Plus2023-06-28
04719883751409APOZASelector U22023-06-28
04719883751416APOZASelector U22023-06-28
04719883751423APOZACAM-II2023-06-28
04719883751447APOZALED Turbo Pen2023-06-28
04719883751454APOZATOP Light Plus2023-06-28
04719883751478APOZATOP Light2023-06-28
04719883751492APOZAMegalight Turbo2023-06-28
04719883751508APOZATOP 3W2023-06-28
04719883751515APOZAMega Light CL2023-06-28
04719883750228APOZABT Cool Plus2023-06-26
04719883750273APOZABT Cool Easy2023-06-26
04719883750464APOZAD20002023-06-26
04719883750549APOZAD20002023-06-26
04719883750624APOZALED 10W2023-06-26
04719883750839APOZAE-MORLIT2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D130BVA6X0BaseVacR. E. Morrison Equipment IncNRD2026-01-12
10371347017875Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017882Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
10371347017899Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017905Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017912Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017929Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-21
10371347017837Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017844Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017851Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
10371347017868Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
D678AS50X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
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