FDA UDI
In Commercial Distribution
🇺🇸 United States
Steri-Sol® Dental Handpiece Cutting Solution
DI: 00854542008334
·
Model: 00854542008334
·
Anodia Systems
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Steri-Sol® Dental Handpiece Cutting Solution
- Primary DI
- 00854542008334
- Version / Model
- 00854542008334
- Catalog Number
- ITEM # MAK-STERI-SOL
- Company Name
- Anodia Systems
- Labeler DUNS
- 030080456
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- e51a4af6-cf0a-444d-9457-fcce5654e4bb
Device Description
Dental Handpiece Cutting/Fluid solution for use with air or electrically driven Dental High-Speed & Dental Low-Speed Handpiece operative procedures (Net contents: 32 fl. ounces)
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 45235 | Dental scaling solution | A liquid substance used in dentistry to soften and partially solubilize a dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose. It will typically contain acid as a solvent (e.g., hydrochloric) and include other elements (e.g., iodine and excipients). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854542008334 | GS1 |
Customer Contacts
- Phone
- 866-246-2548
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K925378 | 000 |