The following data is part of a premarket notification filed by 3m Espe Ag Dental Products with the FDA for Unicem Hm.
| Device ID | K100908 |
| 510k Number | K100908 |
| Device Name: | UNICEM HM |
| Classification | Cement, Dental |
| Applicant | 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Contact | Desi W Soegiarto |
| Correspondent | Desi W Soegiarto 3M ESPE AG DENTAL PRODUCTS ESPE PLATZ Seefeld, Bavaria, DE D-82229 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-01 |
| Decision Date | 2010-06-22 |
| Summary: | summary |