Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prismatik Dentalcraft, Inc. · Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
266 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 | 29 | 0 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 | 30 | 0 |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONEL | Prismatik Dentalcraft, Inc. | 2025-11-18 | 95 | 0 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 | 30 | 0 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 | 142 | 0 |
| K242564 | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical | Prismatik Dentalcraft, Inc. | 2025-03-21 | 205 | 0 |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | 2025-02-25 | 29 | 0 |
| K241493 | Glidewell™ 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2024-09-12 | 107 | 0 |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Den | Prismatik Dentalcraft, Inc. | 2024-07-12 | 164 | 0 |
| K231940 | BruxZir® NOW SRC | Prismatik Dentalcraft, Inc. | 2024-05-15 | 320 | 0 |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | 2024-05-01 | 30 | 0 |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. | 2024-03-20 | 19 | 0 |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | 2024-03-14 | 293 | 0 |
| K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | 2024-02-27 | 70 | 0 |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGL | Prismatik Dentalcraft, Inc. | 2023-11-14 | 32 | 0 |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProAct | Prismatik Dentalcraft, Inc. | 2023-11-14 | 210 | 0 |
| K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bo | Prismatik Dentalcraft, Inc. | 2023-09-26 | 309 | 0 |
| K231347 | BruxZir™ TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023-06-09 | 31 | 0 |
| K230262 | BruxZir™ Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023-05-16 | 105 | 0 |
| K223798 | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | 2023-02-17 | 60 | 0 |
| K220816 | BruxZir NOW | Prismatik Dentalcraft, Inc. | 2022-08-02 | 134 | 0 |
| K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | 2022-06-29 | 89 | 0 |
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022-06-22 | 203 | 0 |
| K214102 | Glidewell Appliance Resin, Hard/Soft | Prismatik Dentalcraft, Inc. | 2022-02-23 | 56 | 0 |
| K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021-11-17 | 27 | 0 |
| K211069 | EndSnorZ Sleep Appliance | Prismatik Dentalcraft, Inc. | 2021-10-26 | 197 | 0 |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | 2021-06-16 | 100 | 0 |
| K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. | 2020-06-10 | 141 | 0 |
| K191903 | BruxZir GT (Gum Tissue) Color | Prismatik Dentalcraft, Inc. | 2019-11-22 | 129 | 0 |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Impla | Prismatik Dentalcraft, Inc. | 2019-08-05 | 90 | 0 |
| K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | 2019-07-17 | 236 | 1 |
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRid | Prismatik Dentalcraft, Inc. | 2017-06-06 | 152 | 0 |
| K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. | 2016-11-16 | 65 | 0 |
| K160979 | Inclusive Abutments | Prismatik Dentalcraft, Inc. | 2016-11-04 | 211 | 0 |
| K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. | 2016-07-15 | 150 | 0 |
| K153099 | INCLUSIVE TAPERED IMPLANT SYSTEM | Prismatik Dentalcraft, Inc. | 2016-05-23 | 210 | 0 |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synO | Prismatik Dentalcraft, Inc. | 2015-11-16 | 137 | 0 |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Imp | Prismatik Dentalcraft, Inc. | 2015-10-07 | 138 | 0 |
| K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw- | Prismatik Dentalcraft, Inc. | 2015-10-01 | 294 | 0 |
| K150872 | BruxZir Anterior Milling Blanks | Prismatik Dentalcraft, Inc. | 2015-07-02 | 92 | 0 |
| K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | 2015-04-02 | 129 | 0 |
| K141923 | INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLA | Prismatik Dentalcraft, Inc. | 2015-01-06 | 174 | 0 |
| K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | 2014-12-15 | 25 | 0 |
| K142118 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE | Prismatik Dentalcraft, Inc. | 2014-11-25 | 113 | 0 |
| K142115 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET | Prismatik Dentalcraft, Inc. | 2014-11-13 | 101 | 1 |
| K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) | Prismatik Dentalcraft, Inc. | 2014-11-06 | 115 | 0 |
| K141211 | INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSU | Prismatik Dentalcraft, Inc. | 2014-10-22 | 166 | 0 |
| K141788 | OBSIDIAN MILLING BLOCKS | Prismatik Dentalcraft, Inc. | 2014-08-20 | 49 | 0 |
| K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | Prismatik Dentalcraft, Inc. | 2014-06-04 | 167 | 0 |
| K130604 | UNIVERSAL PASTE STAINS AND GLAZE | Prismatik Dentalcraft, Inc. | 2013-09-12 | 189 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda