Chrysalis Intelligence · Sponsors · Keystone Industries

Keystone Industries

Gibbstown, NJ, US · 2 510(k) clearances · 3 recalls

Total clearances
2
2024-10-24 → 2025-05-20
Last 12 months
0
Product codes
1
Most recent
2025-05-20
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
EBI 2 2025-05-20
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2023-11-20
DateSeverityStatusRecall # ProductCodeReason
2023-11-20 Class II Ongoing Z-0630-2024 KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua… 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 …
2023-07-21 Class II Ongoing Z-2579-2023 Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amal… A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
2023-04-10 Class II Ongoing Z-2580-2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry S… 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…
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-05-20 K250489 FP3D EBI
2024-10-24 K241089 KeyPrint KeyDenture Base EBI