510(k) K872746
K872746 is an FDA 510(k) premarket notification submitted by Austenal Dental, Inc. for the device "VITALLIUM WIRE". The FDA issued a decision of Substantially Equivalent on July 21, 1987. The device falls under product code EJW (Clasp, Wire), a Class I device regulated under 21 CFR 872.3285. Austenal Dental, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1987
- Date Received
- July 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clasp, Wire
- Device Class
- Class I
- Regulation Number
- 872.3285
- Review Panel
- DE
- Submission Type