CanalPro
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Basic Information
- Brand Name
- CanalPro
- Primary DI
- 00840016202056
- Version / Model
- ENDOBUNDLEXMOV
- Company Name
- COLTENE/WHALEDENT INC
- Labeler DUNS
- 622185718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- 957744db-d41e-4be0-b237-2fb73d467a72
Device Description
Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black printed medium 152x152, 36 pcs (1) MicroMega K-Files B6 n008 L25 Sterile (1) MicroMega K-Files B6 n010 L25 Sterile (1) HyFlex EDM NiTi File Finishing Set, 25mm, 3 pcs (1) CanalPro NAOCL 6% 480 ML (1) Guttapercha points HyFlex EDM OGSF (1) HyFlex EDM Guttapercha Points Assortment, 60 pcs (1) Paper points HyFlex EDM OGSF 30/.04 (1) HyFlex Paper Points EDM Assortment, 100 pcs (1) Motor CanalPro X-Move (5) HyFlex EDM OGSF Sequence, 25mm, 4pcs (1) HyFlex EDM 40/.04 Finisher File, 25mm (1) Paper points HyFlex .04 #40 (1) Guttapercha points HyFlex EDM .04 #40 (5) B5 One RECI n25 6% L25 P. PACK Sterile (1) CanalPro EndoUltra Motor (1) CanalPro EDTA 480ML (1) CanalPro Side-Port Tips, 30ga, 100/bag (1) ROEKO GuttaFlow 2 Standard Set, 5 ml
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAT | Tester, Pulp | Dental | 872.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38787 | Cryogenic spray, dental | A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10840016202053 | GS1 | ||||
| Primary | 00840016202056 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 101 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 77 Degrees Fahrenheit