FDA UDI
In Commercial Distribution
🇺🇸 United States
SIROSONIC
DI: E27665628342
·
Model: 6562834
·
SIRONA Dental Systems GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- SIROSONIC
- Primary DI
- E27665628342
- Version / Model
- 6562834
- Company Name
- SIRONA Dental Systems GmbH
- Labeler DUNS
- 340306351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2022-05-17
- Public Version Status
- Update
- Public Device Record Key
- 2fc7f18c-09c0-4786-ae87-5c194e6e16d7
Device Description
Set SIROSONIC L (2 pc.)
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
- Yes
- 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 |
|---|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44908 | Ultrasonic dental scaling/debridement system handpiece tip, periodontal | An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E27665628342 | HIBCC | ||||
| Unit of Use | E27665638650 | HIBCC |
Customer Contacts
- Phone
- +4962511670
- [email protected]