The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Maxcem 2.
| Device ID | K073209 |
| 510k Number | K073209 |
| Device Name: | MAXCEM 2 |
| Classification | Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief |
| Applicant | KERR CORPORATION 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell KERR CORPORATION 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | MZW |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-14 |
| Decision Date | 2008-01-29 |
| Summary: | summary |