Keystone Industries
52 West King St, Myerstown, PA, US
Registered product codes
52 product codes
Recent MDR events
7 on file
- PROFORMNov 26, 2025Injury3010002722-2025-00004
- KEYSPLINT SOFTAug 15, 2025Injury3010002722-2025-00002
- KEYSPLINT HARDAug 15, 2025Injury3010002722-2025-00003
- FLECK'S DENTAL CEMENTJun 20, 2025Injury3010002722-2025-00001
- FLECK'S DENTAL CEMENTMay 13, 2025InjuryMW5170259
- FLEXO SALIVA EJECTORSFeb 21, 2023Malfunction2523320-2023-00002
- PREHMA DISPOSABLE DENTAL NEEDLESFeb 3, 2023Injury2523320-2023-00001
Recalls
3 on file
- Open, ClassifiedJan 3, 2024
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
View FDA record ↗ - Open, ClassifiedSep 12, 2023
A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
View FDA record ↗ - Open, ClassifiedSep 12, 2023
The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials
View FDA record ↗
Compliance history
Matched by FEI 2523320.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.