510(k) K864059
K864059 is an FDA 510(k) premarket notification submitted by Mission White Dental, Inc. for the device "DENTAL PROPHY CUPS (VARIOUS TYPES)". The FDA issued a decision of Substantially Equivalent on November 19, 1986. The device falls under product code EHK (Cup, Prophylaxis), a Class I device regulated under 21 CFR 872.6290. Mission White Dental, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1986
- Date Received
- October 20, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cup, Prophylaxis
- Device Class
- Class I
- Regulation Number
- 872.6290
- Review Panel
- DE
- Submission Type