510(k) K894059
K894059 is an FDA 510(k) premarket notification submitted by Eurodent, Inc. for the device "ISOLIGHT". The FDA issued a decision of Substantially Equivalent on September 7, 1989. The device falls under product code EAZ (Light, Operating, Dental), a Class I device regulated under 21 CFR 872.4630. Eurodent, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1989
- Date Received
- June 7, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Operating, Dental
- Device Class
- Class I
- Regulation Number
- 872.4630
- Review Panel
- DE
- Submission Type