Identity
- Trade Name
- SOL® FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- SOL LASER INTG WIRELESS-DEALER FDA UDI
- Model / Reference
- LR1001DW FDA UDI
- Description
- SOL LASER INTG WIRELESS-DEALER FDA UDI
Identifiers
- Catalog Number
- LR1001DW FDA UDI
- Primary DI / UDI-DI
- D813LR1001DW0 FDA UDI
- 510(k) Number
- K141838 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Category: Dental diode laser system
Sol® by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141838 also covers:
- BLUEWAVE — Den-Mat Holdings, LLC
- BLUEWAVE — Den-Mat Holdings, LLC
- BLUEWAVE — Den-Mat Holdings, LLC
- BLUEWAVE — Den-Mat Holdings, LLC
- BLUEWAVE — Den-Mat Holdings, LLC
- BLUEWAVE — Den-Mat Holdings, LLC
- Bluewave™ Soft Tissue Diode Laser — Den-Mat Holdings, LLC
- SOL® — Den-Mat Holdings, LLC
- SOL® — Den-Mat Holdings, LLC
- SOL® — Den-Mat Holdings, LLC
- SOL® — Den-Mat Holdings, LLC
- SOL® — Den-Mat Holdings, LLC
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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI de66e054-f9f8-43c8-9657-6879a33760d0 37 fields · synced Jun 9, 2026