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 |