FDA UDI
In Commercial Distribution
🇺🇸 United States
Athena Champion
DI: 00302730001945
·
Model: AC5000-4S
·
YOUNG DENTAL MANUFACTURING I, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Athena Champion
- Primary DI
- 00302730001945
- Version / Model
- AC5000-4S
- Catalog Number
- AC5000-4S
- Company Name
- YOUNG DENTAL MANUFACTURING I, LLC
- Labeler DUNS
- 006309355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-16
- Public Version
- 1
- Public Version Date
- 2022-10-24
- Public Version Status
- New
- Public Device Record Key
- 3851677b-2f59-4467-a69f-3bea9df13bae
Device Description
Athena Champion Handpiece, Standard Head with Bur Tool, Hi Speed, 4 Hold Connector
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10302730001942 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00302730001945 | GS1 |
Customer Contacts
- Phone
- +1(800) 325-1881
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925678 | 000 |