510(k) K961704
K961704 is an FDA 510(k) premarket notification submitted by Dentatus USA , Ltd. for the device "MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM". The FDA issued a decision of Substantially Equivalent on July 26, 1996. The device falls under product code ELS (Splint, Endodontic Stabilizing), a Class II device regulated under 21 CFR 872.3890. Dentatus USA , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1996
- Date Received
- May 2, 1996
- 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