FDA UDI
In Commercial Distribution
🇺🇸 United States
MB-301 Assistina ONE
DI: J021303980011
·
Model: 30398001
·
W & H Dentalwerk Bürmoos GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MB-301 Assistina ONE
- Primary DI
- J021303980011
- Version / Model
- 30398001
- Company Name
- W & H Dentalwerk Bürmoos GmbH
- Labeler DUNS
- 300238441
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-24
- Public Version
- 1
- Public Version Date
- 2022-09-01
- Public Version Status
- New
- Public Device Record Key
- 411a2ee3-7909-46b3-b03a-955239a5b9ef
Device Description
Cleaning/Lubrication Unit
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
- 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 |
|---|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44690 | Dental handpiece maintenance unit | A device used for the automatic internal cleaning, lubrication and maintenance of dental handpieces used in dentistry (e.g., pneumatically or electrically driven scalers, motors, or turbines). This device will automatically run programs for, e.g., the cleaning and/or lubrication of the internal components with service oil, cleaning water/air spray channels with cleaning fluid and flushing with compressed air after external cleansing, but prior to sterilization. This process will improve performance and safety of the dental instruments. The unit is designed to accept different handpiece models, which are connected directly or via adaptors to the unit's processing chamber. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | J021303980010 | HIBCC | ||||
| Primary | J021303980011 | HIBCC |