510(k) K083479
K083479 is an FDA 510(k) premarket notification submitted by Great Lakes Orthodontics, Ltd. for the device "BIOCRYL X". The FDA issued a decision of Substantially Equivalent on February 27, 2009. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Great Lakes Orthodontics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2009
- Date Received
- November 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type