Identity
- Trade Name
- Precise LTM 60° Tip FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Single-use 60° angled handpiece tip for use with the Precise LTM Diode Laser. FDA UDI
- Model / Reference
- 00669 FDA UDI
- Description
- Single-use 60° angled handpiece tip for use with the Precise LTM Diode Laser. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00872320003449 FDA UDI
- 510(k) Number
- K062619 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
No
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: Dental diode laser system
Precise LTM 60° Tip by Cao Group, Inc. — 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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- STERLING® — Den-Mat Holdings, LLC · Class II
- SOL® — Den-Mat Holdings, LLC · Class II
- BLU — Peter Brasseler Holdings, LLC · Class II
- iLase Handpiece — Biolase, Inc. · Class II
- SL3® — Den-Mat Holdings, LLC · Class II
Cleared under the same submission
K062619 also covers:
- Pioneer Pro 60° Tip — CAO GROUP, INC.
- Pioneer Pro Diode Laser — CAO GROUP, INC.
- Pioneer Pro Fiber Cartridge — CAO GROUP, INC.
- Pioneer Pro Straight Tip — CAO GROUP, INC.
- Pioneer Pro Wired Footswitch — CAO GROUP, INC.
- Pioneer Pro Wireless Footswitch — CAO GROUP, INC.
- Precise LTM Diode Laser — CAO GROUP, INC.
- Precise LTM Fiber Cartridge — CAO GROUP, INC.
- Precise LTM Fiber Cleaver — CAO GROUP, INC.
- Precise LTM Handpiece — CAO GROUP, INC.
- Precise LTM Handpiece Collet — CAO GROUP, INC.
- Precise LTM Straight Tip — CAO GROUP, INC.
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 |
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Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (1)
- FDA UDI e742f619-9bcf-427b-9964-6f27123c80e9 34 fields · synced Jun 8, 2026