510(k) K931993
K931993 is an FDA 510(k) premarket notification submitted by The Straumann Co. for the device "ITI DISTANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. The Straumann Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1994
- Date Received
- April 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type