FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rolence
DI: 04713909450604
·
Model: MS-30 HS
·
ROLENCE ENTERPRISE INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rolence
- Primary DI
- 04713909450604
- Version / Model
- MS-30 HS
- Company Name
- ROLENCE ENTERPRISE INC.
- Labeler DUNS
- 656096658
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8cfe0c65-7c0b-47de-867e-4f1423ccce10
- Distribution End Date
- 2016-11-17
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44906 | Ultrasonic dental scaling/debridement system generator | A mains electricity (AC-powered) unit that functions as part of an ultrasonic dental scaling/debridement system, intended to generate, and enable control of, ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It connects to the system handpiece, and may connect to a suitable water supply, or it may contain the water or rinsing solution (e.g., chlorhexidine) source. | No | Active |
| 44907 | Ultrasonic dental scaling/debridement system handpiece | A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04713909450604 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040396 | 000 |