Identity
- Trade Name
- SMARTLITE FOCUS FDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- SmartLite Focus Refill is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as handpiece together a with battery pack. FDA UDI
- Model / Reference
- 64450060 FDA UDI
- Description
- SmartLite Focus Refill is a cordless pen-style, LED light polymerization device for use by trained dental professionals or dental laboratories. SmartLite Focus is received as handpiece together a with battery pack. FDA UDI
Identifiers
- Catalog Number
- 64450060 FDA UDI
- Primary DI / UDI-DI
- D010644500601 FDA UDI
- FDA Product Code
- EBZ FDA UDI
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6070 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Smartlite Focus by Dentsply De Trey GmbH — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentsply De Trey GmbH
Sources (1)
- FDA UDI dfa60ea7-ce1e-45a9-8a8f-30617a524511 36 fields · synced Jun 8, 2026