510(k) K991481
K991481 is an FDA 510(k) premarket notification submitted by Lancer Orthodontics, Inc. for the device "PARAGON". The FDA issued a decision of Substantially Equivalent on August 11, 1999. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Lancer Orthodontics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1999
- Date Received
- April 28, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Amalgam
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type