510(k) K904296
K904296 is an FDA 510(k) premarket notification submitted by Prodent Intl., Inc. for the device "LYSTA HYGIENIST III SCALER". The FDA issued a decision of Substantially Equivalent on Dec 5, 1990. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Prodent Intl., Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 1990
- Date Received
- Sep 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type
- 510(k)