Identity
- Trade Name
- Precise SHP Tips, Variety Pack FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Variety pack of different sizes of laser handpiece tips. FDA UDI
- Model / Reference
- 002-00251 FDA UDI
- Description
- Variety pack of different sizes of laser handpiece tips. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00872320003227 FDA UDI
- 510(k) Number
- K123443 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 600 Micrometer FDA UDIOuter Diameter — 400 Micrometer FDA UDIOuter Diameter — 300 Micrometer FDA UDIOuter Diameter — 200 Micrometer FDA UDI
Category: Dental diode laser system
Precise SHP Tips, Variety Pack 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
K123443 also covers:
- Precise SHP 200um Fiber Tip — CAO GROUP, INC.
- Precise SHP 200um Fiber Tip — CAO GROUP, INC.
- Precise SHP 300um Fiber Tip — CAO GROUP, INC.
- Precise SHP 300um Fiber Tip — CAO GROUP, INC.
- Precise SHP 400um Fiber Tip — CAO GROUP, INC.
- Precise SHP 400um Fiber Tip — CAO GROUP, INC.
- Precise SHP 600um Fiber Tip — CAO GROUP, INC.
- Precise SHP 600um Fiber Tip — CAO GROUP, INC.
- Precise SHP Diode Laser — CAO GROUP, INC.
- Precise SHP Display Barrier Sleeve — CAO GROUP, INC.
- Precise SHP Display Stand — CAO GROUP, INC.
- Precise SHP Display Stand — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cao Group, Inc.
Sources (1)
- FDA UDI 85437fa3-4218-4604-866d-14941a28c6c4 36 fields · synced Jun 8, 2026