The following data is part of a premarket notification filed by Heraeus Kulzer Llc, Mitsui Chemicals Group with the FDA for Ibond Universal & Ibond Ceramic Primer.
| Device ID | K150933 |
| 510k Number | K150933 |
| Device Name: | IBond Universal & IBond Ceramic Primer |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Heraeus Kulzer LLC, Mitsui Chemicals Group 3001 Heraeus Way South Bend, IN 46614 |
| Contact | Jamie Cleveland |
| Correspondent | Jamie Cleveland Heraeus Kulzer LLC, Mitsui Chemicals Group 3001 Heraeus Way South Bend, IN 46614 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660888980 | K150933 | 000 |
| J014660614110 | K150933 | 000 |
| J014660614120 | K150933 | 000 |
| J014660614130 | K150933 | 000 |
| J014660614160 | K150933 | 000 |
| J014660614190 | K150933 | 000 |
| J014660614200 | K150933 | 000 |
| J014660614690 | K150933 | 000 |
| J014660614700 | K150933 | 000 |
| J014660982800 | K150933 | 000 |