FDA UDI
In Commercial Distribution
🇺🇸 United States
PinkWave Kit
DI: 10818207020656
·
Model: 90734
·
Vista Dental
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PinkWave Kit
- Primary DI
- 10818207020656
- Version / Model
- 90734
- Company Name
- Vista Dental
- Labeler DUNS
- 036623932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-29
- Public Version
- 1
- Public Version Date
- 2021-02-08
- Public Version Status
- New
- Public Device Record Key
- fbcb26d1-abfc-4f40-96b0-3074eeb43d8e
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | 872.6070 | 2 |
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 | 10818207020656 | GS1 |
Customer Contacts
- Phone
- 262-636-9755
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170101 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .5 – 1.4 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- .697 – 1.013 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius