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U.S. Department of Health and Human Services

Class 2 Device Recall FP3D

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 Class 2 Device Recall FP3Dsee related information
Date Initiated by FirmOctober 02, 2026
Date PostedNovember 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0426-2027
Recall Event ID 100120
510(K)NumberK250489 
Product Classification Resin, denture, relining, repairing, rebasing - Product Code EBI
ProductFP3D Original Pink; Model/Catalog Number: 4220440; Product Description: The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients. The device is manufactured using dual-cure technology. The resin consists of two parts (Part A and Part B) that are mixed just before printing. Part A is a UV-curable resin, and Part B is a cross-linking diamine agent. When mixed, the resin undergoes free radical polymerization initiated by a photo-initiator in the presence of a UV light source during the 3D printing process. After printing, the device is then thermally cured in an oven to complete polymerization.
Code Information Box Part No. 4230440; Cartridge Part No. 4220440; UDI H66842204400; All lots;
FEI Number 2523320
Recalling Firm/
Manufacturer		 Keystone Industries - Myerstown
52 King St
Myerstown PA 17067-2519
For Additional Information Contact
717-866-7571
Manufacturer Reason
for Recall		Some resin cartridges may have been filled without Part B resin. If an affected cartridge is used, the resin may look discolored when dispensed or after post-curing and printed parts may be less flexible and durable.
FDA Determined
Cause 2		Process control
ActionOn October 13, 2026, URGENT MEDICAL DEVICE NOTIFICATION letters were sent to customers. Actions to be taken: 1. Locate all FP3D inventory, including unopened boxes and any used or unused cartridges. 2. Inspect each unused cartridge from the bottom. If the Part B plunger is not visible (see Figure 3 in the attached notice), set the cartridge aside and dispose of it. Record the number disposed of on the attached form. 3. Dispose of every partially used cartridge, whether or not the plunger is visible. Record the number disposed of onto the attached form. 4. Dispose of any expired inventory. 5. Fill out and sign the attached Acknowledgement Form and return it to FP3D@keystoneind.com within 5 business days, even if you have no affected product on hand. After your form is received, any non-expired product disposed of per the steps above will be replaced.
Quantity in Commerce1112
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EBI
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