The following data is part of a premarket notification filed by Inrterpore Intl. with the FDA for Interpore 200 Porous Hydroxyapatite.
| Device ID | K852975 |
| 510k Number | K852975 |
| Device Name: | INTERPORE 200 POROUS HYDROXYAPATITE |
| Classification | Wire, Orthodontic |
| Applicant | INRTERPORE INTL. P.O. BOX 19369 Irvine, CA 92713 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell INRTERPORE INTL. P.O. BOX 19369 Irvine, CA 92713 |
| Product Code | DZC |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-15 |
| Decision Date | 1985-10-31 |