The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch Single Dose Assortment, Ibond Self.
| Device ID | K123278 |
| 510k Number | K123278 |
| Device Name: | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Contact | Jamie Mearna |
| Correspondent | Jamie Mearna HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-22 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660482610 | K123278 | 000 |
| J014660462450 | K123278 | 000 |
| J014660462440 | K123278 | 000 |
| J014660462430 | K123278 | 000 |