510(k) K931330
K931330 is an FDA 510(k) premarket notification submitted by Minnesota Prophy Power, Inc. for the device "DENTAL INSTRUMENTS SCALER". The FDA issued a decision of Substantially Equivalent on January 26, 1994. The device falls under product code EMN (Scaler, Periodontic), a Class I device regulated under 21 CFR 872.4565. Minnesota Prophy Power, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 26, 1994
- Date Received
- March 16, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Periodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type