The following data is part of a premarket notification filed by Ceramic Core Corp. with the FDA for Ceramic(tm) Abutment.
| Device ID | K913255 |
| 510k Number | K913255 |
| Device Name: | CERAMIC(TM) ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CERAMIC CORE CORP. 6120 BRANDON AVENUE, SUITE 312 Springfield, VA 22150 |
| Contact | Vincent Prestipino |
| Correspondent | Vincent Prestipino CERAMIC CORE CORP. 6120 BRANDON AVENUE, SUITE 312 Springfield, VA 22150 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1994-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747013658 | K913255 | 000 |
| 07332747009774 | K913255 | 000 |
| 07332747009736 | K913255 | 000 |
| 07332747002614 | K913255 | 000 |
| 07332747002560 | K913255 | 000 |