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Monet Curing Laser
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
510(k) K201904Ref 001-00105
Identity
- Trade Name
- Monet Curing Laser EUDAMEDFDA UDI
- Generic Name
- Dental/surgical polymerization lamp FDA UDI
- Device Name
- Monet Curing Laser EUDAMEDHandheld laser device used for polymerizing dental materials. FDA UDI
- Model / Reference
- 001-00105 EUDAMEDFDA UDI
- Description
- Handheld laser device used for polymerizing dental materials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00872320005610 EUDAMEDFDA UDI
- Basic UDI-DI
- 87232000677PM EUDAMED
- Direct Marketing DI
- 00872320005610 EUDAMED
- 510(k) Number
- K201904 FDA 510(k)
- FDA Product Code
- QNF FDA 510(k)FDA UDI
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMED
- GMDN Term
- Dental/surgical polymerization lamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.6070 FDA 510(k)
- Regulation Number
- 872.6070 FDA 510(k)FDA UDI
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Monet Curing Laser by Cao Group, Inc. — Class II — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K201904 | Class II | Active |
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Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (3)
- FDA 510(k) K201904 24 fields · synced Oct 1, 2026
- FDA UDI deb29eec-ff48-4722-a2b8-a219f3c1a183 34 fields · synced May 30, 2026
- EUDAMED a5bb28c0-4ca4-4abc-81f1-72c13f361c66 61 fields · synced Oct 1, 2026