510(k) K972985
K972985 is an FDA 510(k) premarket notification submitted by Jeneric/Pentron, Inc. for the device "SPLINT IT". The FDA issued a decision of Substantially Equivalent on September 24, 1997. The device falls under product code ELS (Splint, Endodontic Stabilizing), a Class II device regulated under 21 CFR 872.3890. Jeneric/Pentron, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1997
- Date Received
- August 11, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Endodontic Stabilizing
- Device Class
- Class II
- Regulation Number
- 872.3890
- Review Panel
- DE
- Submission Type