FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sculpt I.Q.
DI: D8076659283G1
·
Model: 6659283G
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- Sculpt I.Q.
- Primary DI
- D8076659283G1
- Version / Model
- 6659283G
- Catalog Number
- 6659283G
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2018-03-14
- Public Version
- 5
- Public Version Date
- 2024-01-26
- Public Version Status
- Update
- Public Device Record Key
- 035d6050-f08e-4eb3-af06-50a7e2079384
- Distribution End Date
- 2018-04-09
Device Description
EasyTip 320 Pack 25
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, infrared, therapeutic heating | Physical Medicine | 890.5500 | 2 |
| GEX | Powered laser surgical instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60340 | Dental diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D8076659283G1 | HIBCC | ||||
| Unit of Use | D8076659283G0 | HIBCC |
Customer Contacts
- Phone
- +1(800)883-8733
- [email protected]