Keystone Industries

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
3
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0143-2025Class IIBurkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for BuNovember 14, 2024
D-0140-2025Class IIDental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, ManufaNovember 14, 2024
D-0142-2025Class IIHealth-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-3November 14, 2024
D-0147-2025Class IIIpana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.November 14, 2024
D-0139-2025Class IIPrimo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured fNovember 14, 2024
D-0138-2025Class IIM&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), ManufactureNovember 14, 2024
D-0148-2025Class IIHenry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed byNovember 14, 2024
D-0137-2025Class IIGelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone InNovember 14, 2024
D-0146-2025Class IIQuala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), GlNovember 14, 2024
D-0141-2025Class IIPatterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (FaNovember 14, 2024
D-0144-2025Class IIPearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 November 14, 2024
D-0145-2025Class IIsafco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDNovember 14, 2024
D-0046-2025Class IIPerio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.October 17, 2024
Z-0630-2024Class IIKeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mNovember 20, 2023
Z-2579-2023Class IIKeystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal betweenJuly 21, 2023
Z-2580-2023Class IIHenry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.April 10, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K250489FP3DMay 20, 2025
K241089KeyPrint KeyDenture BaseOctober 24, 2024
K183598KeyPrint KeySplint SoftNovember 15, 2019