The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Titanium Abutments, Compatible With Dentsply Implants Ankylos C/x.
| Device ID | K141923 |
| 510k Number | K141923 |
| Device Name: | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612 |
| Contact | Marilyn Pourazar |
| Correspondent | Marilyn Pourazar PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2015-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H65890122370 | K141923 | 000 |
| D745701139COM00340 | K141923 | 000 |
| D745701139COM00330 | K141923 | 000 |
| D745701139COM00320 | K141923 | 000 |
| D745701139COM00310 | K141923 | 000 |
| D745701139COM00300 | K141923 | 000 |
| D745701139COM00290 | K141923 | 000 |
| D745701139COM00130 | K141923 | 000 |
| D745701139COM00190 | K141923 | 000 |
| D745701139COM00140 | K141923 | 000 |
| D745701139COM00690 | K141923 | 000 |
| D745701139COM00410 | K141923 | 000 |
| D745701139COM00420 | K141923 | 000 |
| D745701139COM00430 | K141923 | 000 |
| H65890122360 | K141923 | 000 |
| H65890122350 | K141923 | 000 |
| H65890122340 | K141923 | 000 |
| D745701139COM00530 | K141923 | 000 |
| D745701139COM00520 | K141923 | 000 |
| D745701139COM00510 | K141923 | 000 |
| D745701139COM00500 | K141923 | 000 |
| D745701139COM00460 | K141923 | 000 |
| D745701139COM00450 | K141923 | 000 |
| D745701139COM00440 | K141923 | 000 |
| D745701139COM00680 | K141923 | 000 |