510(k) K891338
K891338 is an FDA 510(k) premarket notification submitted by The Smylon Co. for the device "SMYLON (DENTAL STAIN ERASER)". The FDA issued a decision of Substantially Equivalent on November 14, 1989. The device falls under product code MAU (Eraser, Dental Stain), a Class I device regulated under 21 CFR 872.6855.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1989
- Date Received
- March 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eraser, Dental Stain
- Device Class
- Class I
- Regulation Number
- 872.6855
- Review Panel
- DE
- Submission Type