K083652 is an FDA 510(k) clearance for the IBOND TOTAL ETCH. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on January 21, 2009, 43 days after receiving the submission on December 9, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K083652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2008 |
| Decision Date | January 21, 2009 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |