Identity
- Trade Name
- Sculpt I.Q. FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Handpiece sleeve with keypad FDA UDI
- Model / Reference
- 6659184 FDA UDI
- Description
- Handpiece sleeve with keypad FDA UDI
Identifiers
- Catalog Number
- 6659184 FDA UDI
- Primary DI / UDI-DI
- D74666591841 FDA UDI
- FDA Product Code
- ILY FDA UDIGEX FDA UDI
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sculpt I.Q. by Dentsply Sirona Orthodontics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentsply Sirona Orthodontics Inc.
Sources (1)
- FDA UDI ee2860fb-6ac1-4073-ab7e-5f915bc4fc40 36 fields · synced Jun 9, 2026