FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort-Sonic P9
DI: 00628504370735
·
Model: UL2103
·
Beyes Dental Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comfort-Sonic P9
- Primary DI
- 00628504370735
- Version / Model
- UL2103
- Company Name
- Beyes Dental Canada Inc
- Labeler DUNS
- 244261462
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-12
- Public Version
- 1
- Public Version Date
- 2019-04-22
- Public Version Status
- New
- Public Device Record Key
- 528b5b6b-8c23-4f3d-b2a4-65e7a6776308
Device Description
Ultrasonic Scaler, Direct-LED, Includes 7 Tips, 110V
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31885 | Rotary dental scaler | An abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628504370735 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053555 | 000 |