FDA.reportPublic FDA data

APOZA

Primary DI
04719883751331
Brand
APOZA
Company
APOZA ENTERPRISE CO., LTD.
Model
LIGHT GUIDE-8mm
Device description
Light Guide 8mm. Accessories for APOZA LED Light Curing Unit
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAYLight, Fiber Optic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAYLight, Fiber Optic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719883751331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719883751331047198837513314719883751331

GMDN Terms#

Term, Definition table
TermDefinition
Dental/surgical polymerization lampA mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
656816337
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
04719883751522APOZACAM-I2023-06-28
04719883750228APOZABT Cool Plus2023-06-26
04719883750273APOZABT Cool Easy2023-06-26
04719883750464APOZAD20002023-06-26
04719883750549APOZAD20002023-06-26
04719883750624APOZALED 10W2023-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081400502148503BA-FOQuality Aspirators, Inc.EAY2025-02-27
0081400502150803BAT-FOQuality Aspirators, Inc.EAY2025-02-27
0081400502248276R-FOQuality Aspirators, Inc.EAY2025-02-27
00814005023120HDPQuality Aspirators, Inc.EAY2025-02-27
00814005023267LG316-7Quality Aspirators, Inc.EAY2025-02-27
00814005023274LG316-8Quality Aspirators, Inc.EAY2025-02-27
00814005023281LG316-9Quality Aspirators, Inc.EAY2025-02-27
00814005023380MDPQuality Aspirators, Inc.EAY2025-02-27
00814005023403Minn-SQuality Aspirators, Inc.EAY2025-02-27
00814005023489PE-FOQuality Aspirators, Inc.EAY2025-02-27
00814005023748Seldin 23-FOQuality Aspirators, Inc.EAY2025-02-27
00814005024349HDP-02Quality Aspirators, Inc.EAY2025-02-27
00814005024363MR-FOQuality Aspirators, Inc.EAY2025-02-27
04719883751348APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751362APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751355APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-21
D2483550861FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550871FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550881FOCU-TIP NO.9 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550891FOCU-TIP NO.12 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D836PSLFH9LED Curing LightDENT ZAR, INC.EAY2022-03-07
04560218680945DENTECHDENTECH CORPORATIONEAY2020-09-24
D798LEDBAT0LED BatteryRELIANCE ORTHODONTIC PRODUCTS INCEAY2016-09-20
D798LEDPS0LED PowerslotRELIANCE ORTHODONTIC PRODUCTS INCEAY2016-09-20
00889024133396NAZimmer, Inc.EAY2016-07-25
00889024134317NAZimmer, Inc.EAY2016-07-25
00889024134478NAZimmer, Inc.EAY2016-07-25
00889024134485NAZimmer, Inc.EAY2016-07-25
00889024134492NAZimmer, Inc.EAY2016-07-25
00889024134508NAZimmer, Inc.EAY2016-07-25