510(k) K254009
- Device
- Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
- Applicant
- Lakong Medical Devices Co., Ltd.
- 510(k) number
- K254009
- Product code
- SJH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-10
- Date received
- 2025-12-15
- Regulation
- 872.6640
- Classification name
- Portable Dental Operative Unit
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Zhongliang Wang
- Address
- #13 Jingci Rd., Shilong Dongguan CN 523326 523326
FDA Registration Numbers#
- 3008559238
Source Documents#
510(k) summary PDF not indicated by FDA