The following data is part of a premarket notification filed by Silmet Ltd. with the FDA for Proglass Cements (one, Two Two Lc, Nine, Plus, Silver).
| Device ID | K101869 |
| 510k Number | K101869 |
| Device Name: | PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) |
| Classification | Cement, Dental |
| Applicant | SILMET LTD. 12 HASADNA Or Yehuda, IL 60200 |
| Contact | Sharon Chaplik |
| Correspondent | Sharon Chaplik SILMET LTD. 12 HASADNA Or Yehuda, IL 60200 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-02 |
| Decision Date | 2010-09-29 |
| Summary: | summary |