FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SureSmile®
DI: D746ORX000011
·
Model: ORX00001
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
4
GMDN Terms
2
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- SureSmile®
- Primary DI
- D746ORX000011
- Version / Model
- ORX00001
- Catalog Number
- ORX00001
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- 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
- 42889caf-f90d-4699-8105-db26b8e59edc
- Distribution End Date
- 2023-10-19
Device Description
SureSmile Dr Starter Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 1 |
| EJL | BUR, DENTAL | Dental | 872.3240 | 1 |
| EFB | Handpiece, air-powered, dental | Dental | 872.4200 | 1 |
| EJB | HANDLE, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63358 | Dental abrasive strip, reusable | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D746ORX000010 | HIBCC | ||||
| Primary | D746ORX000011 | HIBCC |
Customer Contacts
- Phone
- +1(833)372-8255
- [email protected]