510(k) K864376
K864376 is an FDA 510(k) premarket notification submitted by Dentec, Inc. for the device "FIBERBOND". The FDA issued a decision of Substantially Equivalent on April 7, 1987. The device falls under product code DYT (Maintainer, Space Preformed, Orthodontic), a Class I device regulated under 21 CFR 872.5525. Dentec, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 1987
- Date Received
- November 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Maintainer, Space Preformed, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5525
- Review Panel
- DE
- Submission Type