510(k) K780752
K780752 is an FDA 510(k) premarket notification submitted by Young Dental Manufacturing Co. 1, LLC for the device "PROPHYLAXIS ANGLE". The FDA issued a decision of Substantially Equivalent on May 26, 1978. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Young Dental Manufacturing Co. 1, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 26, 1978
- Date Received
- May 8, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type