The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Gluma Desensitizer Power Gel.
Device ID | K093575 |
510k Number | K093575 |
Device Name: | GLUMA DESENSITIZER POWER GEL |
Classification | Varnish, Cavity |
Applicant | HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
Contact | Cheryl V Zimmerman |
Correspondent | Cheryl V Zimmerman HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend, IN 46614 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-11-18 |
Decision Date | 2010-03-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
J014660434510 | K093575 | 000 |