Hu-Friedy
- Primary DI
- 10889950140366
- Brand
- Hu-Friedy
- Company
- HU-FRIEDY MFG. CO., LLC
- Model
- UI1030KX
- Device description
- #10 UNIVERSAL STREAMLINE 3.0 30KHz
- Published
- 2023-04-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ELC | Scaler, ultrasonic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10889950140366 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10889950140366 | 10889950140366 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 005085972
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- true
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| 00810126506276 | Dream By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | ELC | 2026-03-05 |
| 00810126506283 | Dream By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | ELC | 2026-03-05 |
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| 00810126506306 | Dream By 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | ELC | 2026-03-05 |
| 00810126506313 | Dream by 3D Dental | 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | ELC | 2026-03-05 |
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