510(k) K000577
K000577 is an FDA 510(k) premarket notification submitted by The Yoshida Dental Mfg. Co., Ltd. for the device "YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA". The FDA issued a decision of Substantially Equivalent on May 5, 2000. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. The Yoshida Dental Mfg. Co., Ltd. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2000
- Date Received
- Feb 22, 2000
- 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)