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Keystone Industries

United States·US-MF-000020203

Last updated September 17, 2026

About

Keystone Industries has maintained a strong reputation for producing high-tech products in the dental, cosmetic, and veterinary industries.

From the manufacturer's own website. Source

Information

Country
United States
Address
52, West King Street, Myerstown, PA, United States
Website
www.keystoneind.com
LinkedIn
linkedin.com/company/keystone-industries
Facebook
facebook.com/KeystoneInd
Email
[email protected]
Phone
717-663-4700
PRRC Contact
Gloria Zuclich
EUDAMED SRN
US-MF-000020203
FDA FEI Number
2523320
DUNS Number
—

Catalogue (909)

Page 2 of 19
DeviceModel / ReferenceRegistriesClassStatus
Sledgehammer 1000511
FDA UDI
Class IIActive
Bosworth 0921487
FDA UDI
Class IActive
Mizzy Millennium 6010022
FDA UDI
Class IIActive
Carbon 4220440
FDA UDI
Class IIActive
Mizzy Millennium 6010038
FDA UDI
Class IIActive
Proform 9603600
FDA UDI
UActive
Mizzy Comfort Cushion 6070100
FDA UDI
Class IActive
Versacryl 1014011
FDA UDI
Class IIActive
Proform 9640966
EUDAMEDFDA UDI
Class IActive
Sledgehammer 1000544
FDA UDI
Class IIActive
Proform 9615000R2
EUDAMEDFDA UDI
Class IActive
Enamelite 5100180
FDA UDI
Class IIActive
KeyMill 1009312
EUDAMEDFDA UDI
Class IIActive
Prehma 27-01110
FDA UDI
Class IActive
Keystone Industries 7000320
FDA UDI
Class IActive
Mizzy Millennium 1014325
FDA UDI
Class IIActive
Proform 9640967R1
EUDAMEDFDA UDI
Class IActive
Bosworth 16677C
FDA UDI
Class IActive
American Dental 21-026
FDA UDI
Class IActive
Gelato 24-08177
FDA UDI
Class IActive
Keystone Industries 1271100
FDA UDI
Class IActive
Sledgehammer 1000547
FDA UDI
Class IIActive
Diamond D 1013098
FDA UDI
Class IIActive
Sky Dental SKY003
FDA UDI
Class IActive
Proform 9615040
EUDAMEDFDA UDI
Class IActive
Gelato 24-15877
EUDAMEDFDA UDI
Class IActive
Sledgehammer 1000507
FDA UDI
Class IIActive
Prehma 05-06748
FDA UDI
Class IActive
Sledgehammer 1000500
FDA UDI
Class IIActive
Sledgehammer 1000504
FDA UDI
Class IIActive
Bosworth 0921422
FDA UDI
Class IActive
Mizzy Millennium 6010024
FDA UDI
Class IIActive
Proform 9614780
EUDAMEDFDA UDI
Class IActive
Prehma 05-10448
FDA UDI
Class IActive
Gelato 24-11577
FDA UDI
Class IActive
Prehma 05-07448
FDA UDI
Class IActive
Keystone Industries 1810060
FDA UDI
Class IActive
Mizzy 6070520
FDA UDI
Class IActive
Proform 9614815
FDA UDI
Class IActive
Prehma 05-02248
FDA UDI
Class IActive
Sledgehammer 1001974
FDA UDI
Class IIActive
Prehma 05-81648
FDA UDI
Class IActive
Proform 9615040R1
EUDAMEDFDA UDI
Class IActive
Procure 9634600
FDA UDI
Class IIActive
Diamond D 1013091
EUDAMEDFDA UDI
Class IIActive
Keystone Industries 1270006
FDA UDI
Class IActive
Diamond D 1014265
FDA UDI
Class IIActive
Sledgehammer 1001970
FDA UDI
Class IIActive
Keystone Industries 1147578
FDA UDI
Class IActive
Sledgehammer 1000471
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Nov 20, 2023Z-0630-2024—open, classified

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).

Jul 21, 2023Z-2579-2023—open, classified

A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

Apr 10, 2023Z-2580-2023—open, classified

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