510(k) K970104
K970104 is an FDA 510(k) premarket notification submitted by Dw Industries, Inc. for the device "SANI-SHIELD". The FDA issued a decision of Substantially Equivalent on May 6, 1997. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dw Industries, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1997
- Date Received
- January 13, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Air-Powered, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type