510(k) K872471
K872471 is an FDA 510(k) premarket notification submitted by Titane SL Co. for the device "TITANE SL DENTAL BURR". The FDA issued a decision of Substantially Equivalent on September 11, 1987. The device falls under product code ECM (Band, Preformed, Orthodontic), a Class I device regulated under 21 CFR 872.5410.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1987
- Date Received
- June 23, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Band, Preformed, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5410
- Review Panel
- DE
- Submission Type