The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Retrieve Implant Cement.
| Device ID | K101044 |
| 510k Number | K101044 |
| Device Name: | RETRIEVE IMPLANT CEMENT |
| Classification | Cement, Dental |
| Applicant | PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Contact | Daniel R Schechter |
| Correspondent | Daniel R Schechter PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-06-10 |
| Summary: | summary |