510(k) K251491
K251491 is an FDA 510(k) premarket notification submitted by Osstem Implant Company., Ltd. Chair Business for the device "K5 Cart, K5 Mount, K5 Swing". The FDA issued a decision of Substantially Equivalent on July 17, 2025. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2025
- Date Received
- May 14, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type