510(k) K760323
K760323 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "X-RAY UNIT, DENTAL DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. The S. S. White Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 3, 1976
- Date Received
- July 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, X-Ray, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.1810
- Review Panel
- RA
- Submission Type