FDA UDI
In Commercial Distribution
🇺🇸 United States
CanalPro
DI: D661H8CPCLINTRO0
·
Model: H8CPCLINTRO
·
COLTENE/WHALEDENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CanalPro
- Primary DI
- D661H8CPCLINTRO0
- Version / Model
- H8CPCLINTRO
- Company Name
- COLTENE/WHALEDENT INC
- Labeler DUNS
- 622185718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-11
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- d49f076b-6be8-4d55-954e-f214b2dca39a
Device Description
CanalPro CL Intro Kit
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 |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63498 | Dental power tool system handpiece, battery-powered | A hand-held, electrically-powered dental device that includes a chuck or collet for attaching a rotary dental endpiece (e.g., polishing brush) intended to be used in dental procedures, typically for cleaning and polishing teeth. It is a battery-powered cordless instrument with an integral electric motor and push buttons for controlling the device settings; the endpiece(s) is not included. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D661H8CPCLINTRO0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K990682 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .5 – 1.06 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- .5 – 1.06 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius