FDA Registration
Active
🇺🇸 United States
Advanced Endodontic System
Reg #: 1722638
·
FEI: 1000160293
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ASI MEDICAL, INC.
- Registration Number
- 1722638
- FEI Number
- 1000160293
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8811 AMERICAN WAY STE 130
- City
- ENGLEWOOD
- State
- CO
- ZIP
- 80112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123139
Owner / Operator
- Firm Name
- ASI MEDICAL, INC.
- Operator Number
- 9008677
- Address
- 8811 American Way, SUITE 130
- City
- Englewood
- State
- CO
- Postal Code
- 80112
- Country
- US
- Correspondent
- JOHN W MCPEEK
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2013-10-30 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2013-10-30 |
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2013-10-30 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2013-10-30 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2013-10-30 |
| Handpiece, Belt And/Or Gear Driven, Dental | EFA | Class 1 | Dental | No | 2013-10-30 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2013-10-30 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2013-10-30 |
Proprietary Names
Advanced Endodontic System
Advanced Dental System
Triton Dental System
Establishment Types
Manufacture Medical Device