The following data is part of a premarket notification filed by Produits Dentaires Pierre Rolland with the FDA for Sulcus Blue.
| Device ID | K111978 |
| 510k Number | K111978 |
| Device Name: | SULCUS BLUE |
| Classification | Cord, Retraction |
| Applicant | PRODUITS DENTAIRES PIERRE ROLLAND 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| Contact | Rick Rosati |
| Correspondent | Rick Rosati PRODUITS DENTAIRES PIERRE ROLLAND 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054 |
| 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 | 2011-07-12 |
| Decision Date | 2011-10-13 |
| Summary: | summary |