Prismatik Dentalcraft, Inc. is one of 12917 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Prismatik Dentalcraft, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Glidewell™ Denture Base Resin, Obsidian® Press Over Zirconia, BruxZir® Shaded 16 PLUS
59
Total
59
Cleared
0
Denied
Prismatik Dentalcraft, Inc. has 59 FDA 510(k) cleared dental devices. Based in Newport Beach, US.
Latest FDA clearance: Aug 2026. Active since 2010.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by PaxMed International, LLC and Qserve Group, Us, Inc..
FDA 510(k) Regulatory Record - Prismatik Dentalcraft, Inc.
59 devices
Cleared
Aug 27, 2026
Glidewell™ Denture Base Resin
Dental
87d
Cleared
Jul 30, 2026
Obsidian® Press Over Zirconia
Dental
29d
Cleared
Jan 30, 2026
BruxZir® Shaded 16 PLUS
Dental
30d
Cleared
Nov 18, 2025
Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant...
Dental
95d
Cleared
Sep 03, 2025
BruxZir® NOW
Dental
30d
Cleared
Jun 25, 2025
Flexible Partial Resin
Dental
142d
Cleared
Mar 21, 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell...
General Hospital
205d
Cleared
Feb 25, 2025
BruxZir® Esthetic NOW
Dental
29d
Cleared
Sep 12, 2024
Glidewell™ 3DP Denture Base Resin
Dental
107d
Cleared
Jul 12, 2024
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®,...
Dental
164d
Cleared
May 15, 2024
BruxZir® NOW SRC
Dental
320d
Cleared
May 01, 2024
BruxZir® Esthetic
Dental
30d
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