Aladdin
Basic Information
- Brand Name
- Aladdin
- Primary DI
- 08800017900049
- Version / Model
- Aladdin
- Company Name
- DXM CO., LTD
- Labeler DUNS
- 688797315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-20
- Public Version
- 1
- Public Version Date
- 2023-06-28
- Public Version Status
- New
- Public Device Record Key
- 534d1996-e4b5-4cf6-b2c7-c4d05901fcd2
Device Description
This visible ray curing light is a device to enhance a bleaching effect by exposing a visible ray to teeth with a bleaching agent is designed to be used in dental clinics. This device emits 440 - 50nm blue visible ray by using 3 pieces of L.E.D (Light-Emitting Diode). It is a wireless type device and is convenient to move inside of the clinic. . Aladdin features are: - Easy to operate with touch switches to control the light intensity or operation time. - Easy to carry or move. Once charged, the power code is not necessary to keep plugged in during operation. - Removable parts like head, recharging unit, adapter, pole & foot. - Adjustable light intensity. Left, Center & Right LEDs have 3 grades of light intensity (High, Normal & Low). - Easy to store.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31806 | Tooth-bleaching acceleration unit | A heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800017900049 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 60 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 45 Degrees Celsius