FDA UDI
In Commercial Distribution
🇺🇸 United States
Hydrolux by 3D Dental
DI: 00817169028017
·
Model: HP-C
·
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Hydrolux by 3D Dental
- Primary DI
- 00817169028017
- Version / Model
- HP-C
- Company Name
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Labeler DUNS
- 080194935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-11
- Public Version
- 1
- Public Version Date
- 2026-03-19
- Public Version Status
- New
- Public Device Record Key
- 2411319c-b63d-4336-8e4f-d3e9211095cd
Device Description
HYDROLUX CERAMIC CARTRIDGE
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64225 | Pneumatic dental power tool system handpiece tip, reusable | A removable endpiece intended to be attached to a pneumatic dental power tool system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to mechanically fragment and/or cut bone tissue during a variety of dental surgery procedures, or to apply vibration during restoration placement. It is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is made of metallic or plastic materials; it is not intended to be held directly (i.e., does not include a holder). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817169028017 | GS1 |