510(k) K260275
K260275 is an FDA 510(k) premarket notification submitted by Guangdong JINME Medical Technology Co., Ltd. for the device "Mobile Dental Solution (Model: DS50, DS70, DS90)". The FDA issued a decision of Substantially Equivalent on Oct 23, 2026. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Guangdong JINME Medical Technology Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2026
- Date Received
- Jan 29, 2026
- Clearance Type
- Traditional
- 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
- 510(k)