Prismatik Dentalcraft, Inc.: FDA clearances and approvals
Prismatik Dentalcraft, Inc. has 59 FDA 510(k) clearances (first 2010, latest 2026), across 9 product codes in 2 review panels. Median 510(k) review time: 129 days. Since 2017 its median was 100 days, against 161 days for all cleared 510(k)s in the same product codes. openFDA lists 4 product recalls by a recalling firm named Prismatik Dentalcraft, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 215 |
| 2013 | 3 | 189 |
| 2014 | 7 | 113 |
| 2015 | 6 | 138 |
| 2016 | 4 | 180 |
| 2017 | 1 | 152 |
| 2018 | 0 | — |
| 2019 | 3 | 129 |
| 2020 | 1 | 141 |
| 2021 | 3 | 100 |
| 2022 | 4 | 112 |
| 2023 | 6 | 82 |
| 2024 | 7 | 107 |
| 2025 | 5 | 95 |
| 2026 | 3 | 30 |
Review time against the same product codes
Since 2017, Prismatik Dentalcraft, Inc.'s cleared 510(k)s took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 21 | 21 |
| NHA | Abutment, Implant, Dental, Endosseous | 19 | 19 |
| DZE | Implant, Endosseous, Root-Form | 4 | 4 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| LRK | Device, Anti-Snoring | 4 | 4 |
| EBF | Material, Tooth Shade, Resin | 3 | 3 |
| MQC | Mouthguard, Prescription | 2 | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 | 1 |
Review panels
- Dental (58)
- General Hospital (1)
Most recent Prismatik Dentalcraft, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261802 | Glidewell Denture Base Resin | EBI | 2026-08-27 | 87 |
| K262239 | Obsidian® Press Over Zirconia | EIH | 2026-07-30 | 29 |
| K254283 | BruxZir® Shaded 16 PLUS | EIH | 2026-01-30 | 30 |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | NHA | 2025-11-18 | 95 |
| K252446 | BruxZir® NOW | EIH | 2025-09-03 | 30 |
| K250302 | Flexible Partial Resin | EBI | 2025-06-25 | 142 |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | KCT | 2025-03-21 | 205 |
| K250223 | BruxZir® Esthetic NOW | EIH | 2025-02-25 | 29 |
| K241493 | Glidewell 3DP Denture Base Resin | EBI | 2024-09-12 | 107 |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | NHA | 2024-07-12 | 164 |
49 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 3 initiated in the last five years. Most recent: 2026-04-27.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Prismatik Dentalcraft, Inc. have?
Prismatik Dentalcraft, Inc. has 59 FDA 510(k) clearances (first 2010, latest 2026), across 9 product codes in 2 review panels.
How long does FDA take to clear Prismatik Dentalcraft, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Prismatik Dentalcraft, Inc.'s cleared 510(k)s is 129 days. Since 2017: 100 days, versus 161 days for all cleared 510(k)s in the same product codes.
What devices does Prismatik Dentalcraft, Inc. make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 21); NHA (Abutment, Implant, Dental, Endosseous, 19); DZE (Implant, Endosseous, Root-Form, 4).
Has Prismatik Dentalcraft, Inc. had device recalls?
openFDA lists 4 product recalls in 4 recall events by a recalling firm whose name matches Prismatik Dentalcraft, Inc; the most recent began 2026-04-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 59 Prismatik Dentalcraft, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Prismatik Dentalcraft, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.