FDA UDI
In Commercial Distribution
🇺🇸 United States
Advanced Dental System
DI: 00850309007152
·
Model: 90-2115D
·
ASI MEDICAL, INC.
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advanced Dental System
- Primary DI
- 00850309007152
- Version / Model
- 90-2115D
- Catalog Number
- 90-2115D
- Company Name
- ASI MEDICAL, INC.
- Labeler DUNS
- 808695159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- e6c7b757-3d12-4ae7-a15d-a5cc0deaf272
Device Description
Advanced Dental System
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LQY | Locator, Root Apex | Unknown | U | |
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
| EKR | Plugger, Root Canal, Endodontic | Dental | 872.4565 | 1 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | Dental | 872.4200 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | 872.6070 | 2 |
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
| EIA | Unit, Operative Dental | Dental | 872.6640 | 1 |
| ELC | Scaler, Ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60930 | Dental delivery system instrument unit, electric | A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850309007152 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123139 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity