The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive Titanium Abutments For Astra Tech Osseospeed Implants.
| Device ID | K100993 |
| 510k Number | K100993 |
| Device Name: | INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Contact | Keith Allred |
| Correspondent | Keith Allred PRISMATIK DENTALCRAFT, INC. 4141 MACARTHUR BLVD. Newport Beach, CA 92660 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-09 |
| Decision Date | 2010-12-28 |
| Summary: | summary |