510(k) K781882
K781882 is an FDA 510(k) premarket notification submitted by Vacudent Sales Corp. for the device "MODULAT DENTAL SYSTEMS". The FDA issued a decision of Substantially Equivalent on December 28, 1978. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Vacudent Sales Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1978
- Date Received
- October 24, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type