K242435
- 510(k) number
- K242435
- Device name
- Dental Barrier and Sleeves
- Applicant
- Wellmed Dental Medical Supply Co., Ltd. CN
- Product code
- PEM — Dental Barriers And Sleeves
- Decision date
- 2024-10-18
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K242435
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.