FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SpaceFile®
DI: D74640027MOT1
·
Model: 40027MOT
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpaceFile®
- Primary DI
- D74640027MOT1
- Version / Model
- 40027MOT
- Catalog Number
- 40027MOT
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-01
- Public Version
- 2
- Public Version Date
- 2023-10-19
- Public Version Status
- Update
- Public Device Record Key
- 8f946d42-cb54-42ef-8a04-3903267bdc83
- Distribution End Date
- 2023-10-19
Device Description
SpaceFile® Air Motor
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62725 | Dental delivery system instrument unit, pneumatic | A pneumatically-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 | D74640027MOT1 | HIBCC |
Customer Contacts
- Phone
- +1(833)372-8255
- [email protected]