FDA UDI
In Commercial Distribution
🇺🇸 United States
LED Curing Light
DI: D836PSLFH9
·
Model: 1
·
DENT ZAR, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LED Curing Light
- Primary DI
- D836PSLFH9
- Version / Model
- 1
- Catalog Number
- 2023
- Company Name
- DENT ZAR, INC.
- Labeler DUNS
- 789664455
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-07
- Public Version
- 1
- Public Version Date
- 2022-03-15
- Public Version Status
- New
- Public Device Record Key
- ef86d2b0-527c-46dd-af83-09d22c74d3df
Device Description
A 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 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
- Yes
- 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 |
|---|---|---|---|---|
| EAY | Light, Fiber Optic, Dental | Dental | 872.4620 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35775 | Dental/surgical polymerization lamp | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D836PSLFH9 | HIBCC |