The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Ibond Total Etch.
| Device ID | K083652 |
| 510k Number | K083652 |
| Device Name: | IBOND TOTAL ETCH |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl Zimmerman |
| Correspondent | Cheryl Zimmerman HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660482620 | K083652 | 000 |
| J014660400940 | K083652 | 000 |
| J014660400930 | K083652 | 000 |
| J014660398700 | K083652 | 000 |
| J014660398670 | K083652 | 000 |
| J014660398660 | K083652 | 000 |