Identity
- Trade Name
- BLUEWAVE FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- CCD DISP PERIO TIPS 9mm 300um FDA UDI
- Model / Reference
- LR1010CCD FDA UDI
- Description
- CCD DISP PERIO TIPS 9mm 300um FDA UDI
Identifiers
- Catalog Number
- LR1010CCD FDA UDI
- Primary DI / UDI-DI
- D813LR1010CCD1 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
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 300 Micrometer FDA UDI
Category: Dental diode laser system
Bluewave by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental diode laser system.
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- iLase Handpiece — Biolase, Inc. · Class II
- STERLING — BENCO DENTAL SUPPLY CO. · Class II
- Pioneer Pro Fiber Cartridge — CAO GROUP, INC. · Class II
- STERLING — BENCO DENTAL SUPPLY CO. · Class II
- Pioneer Elite Standard Fiber Tip — CAO GROUP, INC. · Class II
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™ 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
- 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 e7355cd9-5ff1-4077-9795-44922ba1c3cb 37 fields · synced Jun 9, 2026