510(k) K802716
K802716 is an FDA 510(k) premarket notification submitted by Den-Mat Corp. for the device "DEN-MAT FIBER OPTIC HALOGEN LIGHT". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code EAY (Light, Fiber Optic, Dental), a Class I device regulated under 21 CFR 872.4620. Den-Mat Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 31, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Fiber Optic, Dental
- Device Class
- Class I
- Regulation Number
- 872.4620
- Review Panel
- DE
- Submission Type