# Prismatik Dentalcraft, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 59 (2010–2026): 59 510(k) clearances
- Product codes: EIH (21), NHA (19), DZE (4), LRK (4), EBI (4), EBF (3), MQC (2), PNP (1), KCT (1)
- 510(k) review time since 2016: median 103 days, against 129 for FDA's reviews in the same codes and years (21 of 36 faster)
- Predicates its devices cite: 76 (33 its own); citations of its devices by later devices: 53 (33 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inclusive Dental Solutions: 5 (https://510kreport.com/company/inclusive-dental-solutions)
- Astra Tech, Inc.: 5 (https://510kreport.com/company/astra-tech)
- Nobel Biocare AB: 3 (https://510kreport.com/company/nobel-biocare)
- Ivoclar Vivadent, Inc.: 3 (https://510kreport.com/company/ivoclar-vivadent)
- Keystone Industries: 2 (https://510kreport.com/company/keystone-industries)
- Biomet 3i, Inc.: 2 (https://510kreport.com/company/biomet-3i)
- Zimmer Dental, Inc.: 2 (https://510kreport.com/company/zimmer-dental)
- Zirkonzahn Srl: 2 (https://510kreport.com/company/zirkonzahn)

## Firms that cite its devices most
- Biodenta Swiss AG: 3 (https://510kreport.com/company/biodenta-swiss)
- Hass Corp.: 2 (https://510kreport.com/company/hass)
- Preat Corporation: 1 (https://510kreport.com/company/preat)
- Park Dental Research Corp.: 1 (https://510kreport.com/company/park-dental-research)
- U&C International Co., Ltd.: 1 (https://510kreport.com/company/u-c-international)
- Sterngold Dental, LLC: 1 (https://510kreport.com/company/sterngold-dental)
- Ccri, Inc.: 1 (https://510kreport.com/company/ccri)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Its most-cited devices
- K100993: Inclusive Titanium Abutments for Astra Tech Osseospeed Implants (2010), cited by 5
- K143330: BruxZir Anterior (2014), cited by 4
- K130924: Bruxzir Shaded (2013), cited by 4
- K191222: Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV (2019), cited by 4
- K100932: Inclusive Mini Implant (2010), cited by 3
- K121406: Inclusive Tapered Implant System (2013), cited by 3

## Recent decisions
- K261802: Glidewell™ Denture Base Resin (Aug 27, 2026)
- K262239: Obsidian® Press Over Zirconia (Jul 30, 2026)
- K254283: BruxZir® Shaded 16 PLUS (Jan 30, 2026)
- K252582: Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems (Nov 18, 2025)
- K252446: BruxZir® NOW (Sep 3, 2025)
- K250302: Flexible Partial Resin (Jun 25, 2025)
- K242564: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) (Mar 21, 2025)
- K250223: BruxZir® Esthetic NOW (Feb 25, 2025)

Source page: https://510kreport.com/company/prismatik-dentalcraft