510(k) K792307
K792307 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "DENTIX DENTAL X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on Jan 9, 1980. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Precise Optics has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 9, 1980
- Date Received
- Nov 16, 1979
- 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
- 510(k)