PRISMATIK DENTALCRAFT, INC.
Registration 3011649314FEI 3011649314Irvine, CA
Owner/operator: PRISMATIK DENTALCRAFT, INC.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 95
- Added, last 12 months
- 9
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 95
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| NHA | Inclusive® GL Titanium Abutment 4.5 mmH compatible with: BioHorizons® Tapered Internal 3 mmAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K223496 |
| NHA | 17 Degree Multi-Unit Abutment 2 mmH compatible with: Camlog Screw-Line 3.8 mmAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K121391 |
| NHA | Inclusive® GL Titanium Abutment 4.5 mmH compatible with: CONELOG® 3.3 mmAbutment, Implant, Dental, EndosseousAdded Nov 24, 2025 | Class 2 | 21 CFR 872.3630 | K252582 |
| NHA | TRI Zirconia Crown AbutmentAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | — |
| NHA | Inclusive GL Titanium Abutment 4.5 mmH compatible with: Dentsply Implants Astra Tech Implant System EV 4.8Abutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K191222 |
| NHA | Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 3 ImplantAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K160979 |
| NHA | Glidewell IH Implant 15° Titanium Esthetic Abutment, Anterior, 3 mmP x 1.5 mmHAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K153099 |
| NHA | Inclusive GL Titanium Abutment 4.5 mmH compatible with: Straumann Tissue Level RN synOctaAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K151798 |
| NHA | Custom Impression Coping Screw for Zimmer Screw-VentAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K142115 |
| NHA | BruxZir® NOW SRC for Glidewell HT Implant System 3.5/4.3mmD, A1Abutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K231940 |
| NHA | Inclusive GL Titanium Abutment 4.5 mmH compatible with: MegaGen AnyRidge Implant SystemAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K170044 |
| NHA | Inclusive® Implant Bridge FrameworkAbutment, Implant, Dental, Endosseous | Class 2 | 21 CFR 872.3630 | K120858 |
and 83 more on your full dossier
What changed
- Nov 24, 2025Listing added: NHA — Inclusive® GL Titanium Abutment 4.5 mmH compatible with: CONELOG® 3.3 mm (K252582)
- Aug 24, 2026Listing added: EIH — Obsidian® Press Over Zirconia HT1 - 12mm/6g/3 Ingots (K262239)
- Sep 10, 2026Listing added: EBI — Glidewell Denture Base Resin Shade G1 (K261802)
- Jan 23, 2026Listing added: EBI — Glidewell 3DP Denture Base Resin - Shade G1 (K241493)
- Nov 17, 2025Listing added: EBW — Controller, Foot, Handpiece And Cord (K203706)
- Apr 9, 2026Listing added: QDO — Fentanyl And Other Opioid Protection Glove (K202003)
- Nov 17, 2025Listing added: EGS — Handpiece, Contra- And Right-Angle Attachment, Dental (K203706)
- Apr 9, 2026Listing added: LZC — Medical Glove, Specialty (K202003)
- Apr 9, 2026Listing added: LZA — Polymer Patient Examination Glove (K202003)