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 |