The following data is part of a premarket notification filed by Silmet Ltd. with the FDA for Prolink Adhesives (prolink, Prolink Se).
| Device ID | K110403 |
| 510k Number | K110403 |
| Device Name: | PROLINK ADHESIVES (PROLINK, PROLINK SE) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SILMET LTD. 12 HASSADNA ST. Or Yehuda, IL 60200 |
| Contact | Moshe Zalsman |
| Correspondent | Moshe Zalsman SILMET LTD. 12 HASSADNA ST. Or Yehuda, IL 60200 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-11 |
| Decision Date | 2011-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016787627 | K110403 | 000 |
| 07290016787474 | K110403 | 000 |
| 07290016787467 | K110403 | 000 |
| 07290016787450 | K110403 | 000 |
| 07290015358859 | K110403 | 000 |
| 07290015358842 | K110403 | 000 |
| 07290015358835 | K110403 | 000 |