The following data is part of a premarket notification filed by Produits Dentaires Pierre Rolland with the FDA for Expa-syl.
| Device ID | K050180 |
| 510k Number | K050180 |
| Device Name: | EXPA-SYL |
| Classification | Cord, Retraction |
| Applicant | PRODUITS DENTAIRES PIERRE ROLLAND 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell PRODUITS DENTAIRES PIERRE ROLLAND 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-26 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040025994 | K050180 | 000 |
| 03760243007040 | K050180 | 000 |
| 03760243009822 | K050180 | 000 |
| 03760243009839 | K050180 | 000 |
| 03760243000775 | K050180 | 000 |
| 03760243000782 | K050180 | 000 |
| 03760243007033 | K050180 | 000 |
| 03760243001048 | K050180 | 000 |
| 00304040025970 | K050180 | 000 |
| 03760243009808 | K050180 | 000 |