Device Classification Name |
Abutment, Implant, Dental, Endosseous
|
510(k) Number |
K191222 |
Device Name |
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV |
Applicant |
Prismatik Dentalcraft, Inc. |
2212 Dupont Drive, Suite P |
Irvine,
CA
92612
|
|
Applicant Contact |
Herbert Schoenhoefer |
Correspondent |
PaxMed International, LLC |
12264 El Camino Real, Suite 400 |
San Diego,
CA
92130
|
|
Correspondent Contact |
Kevin A. Thomas |
Regulation Number | 872.3630 |
Classification Product Code |
|
Date Received | 05/07/2019 |
Decision Date | 08/05/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|