Identity
- Trade Name
- StarDental Instrument Solutions FDA UDI
- Generic Name
- Medical device light source controller FDA UDI
- Device Name
- STARBRIGHT SINGLE LAMP CONTROL SYSTEM FDA UDI
- Model / Reference
- 265677 FDA UDI
- Description
- STARBRIGHT SINGLE LAMP CONTROL SYSTEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- D7022656770 FDA UDI
- 510(k) Number
- K944271 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Medical device light source controller FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device light source controller
StarDental Instrument Solutions by Dentalez, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device light source controller.
- StarDental Instrument Solutions — DENTALEZ, INC. · Class I
Cleared under the same submission
K944271 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentalez, Inc.
Sources (1)
- FDA UDI d5b11509-3564-4487-8cfd-5c011850a2af 35 fields · synced Jun 8, 2026