510(k) K242435
K242435 is an FDA 510(k) premarket notification submitted by Wellmed Dental Medical Supply Co., Ltd. for the device "Dental Barrier and Sleeves". The FDA issued a decision of Substantially Equivalent on October 18, 2024. The device falls under product code PEM (Dental Barriers And Sleeves), a Class II device regulated under 21 CFR 878.4370. Wellmed Dental Medical Supply Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 2024
- Date Received
- August 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Barriers And Sleeves
- Device Class
- Class II
- Regulation Number
- 878.4370
- Review Panel
- DE
- Submission Type
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.