510(k) K925349
K925349 is an FDA 510(k) premarket notification submitted by Implant Support Systems, Inc. for the device "ONE SYSTEM TAPERED TITANIUM ABUTMENTS". The FDA issued a decision of Substantially Equivalent on July 27, 1993. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Implant Support Systems, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1993
- Date Received
- October 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abutment, Implant, Dental, Endosseous
- Device Class
- Class II
- Regulation Number
- 872.3630
- Review Panel
- DE
- Submission Type
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.