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 |