510(k) K070127
K070127 is an FDA 510(k) premarket notification submitted by Kevin Vu, Dds for the device "PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02". The FDA issued a decision of Substantially Equivalent on March 29, 2007. The device falls under product code EMN (Scaler, Periodontic), a Class I device regulated under 21 CFR 872.4565.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2007
- Date Received
- January 16, 2007
- 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