Identity
- Trade Name
- Precise LTM Handpiece FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Replacement handpiece for the Precise LTM. FDA UDI
- Model / Reference
- 002-00203 FDA UDI
- Description
- Replacement handpiece for the Precise LTM. FDA UDI
Identifiers
- Catalog Number
- 002-00203 FDA UDI
- Primary DI / UDI-DI
- 00872320001391 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental diode laser system
Precise LTM Handpiece by Cao Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
- NV®PRO3 — Den-Mat Holdings, LLC · Class II
- NV® — Den-Mat Holdings, LLC · Class II
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
- 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 60° Tip — 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 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 4cf1c7a6-dc9e-4c1a-8add-59d2b7a4e6e7 36 fields · synced May 30, 2026