The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Cranioplastic, Acrylic Cranioplasty Material.
| Device ID | K873689 |
| 510k Number | K873689 |
| Device Name: | CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | John Semmelman |
| Correspondent | John Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-11 |
| Decision Date | 1987-10-26 |