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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 16 of 19
DeviceModel / ReferenceRegistriesClassStatus
Pure Life 24-42687
FDA UDI
Class IActive
Diamond D 1013115
FDA UDI
Class IIActive
Proflex 9640890
FDA UDI
Class IIActive
Diamond D 1013020
EUDAMEDFDA UDI
Class IIActive
Keystone Industries 1271300
FDA UDI
Class IActive
Proform 9614860
EUDAMEDFDA UDI
Class IActive
Prehma 05-07148
FDA UDI
Class IActive
Prehma 27-00710
FDA UDI
Class IActive
Diamond D 1013018
FDA UDI
Class IIActive
Sledgehammer 1001967
FDA UDI
Class IIActive
Pure Life 24-42686
FDA UDI
Class IActive
Proform 9614870R1
FDA UDI
Class IActive
Prehma 05-03548
FDA UDI
Class IActive
Prehma 05-25148
FDA UDI
Class IActive
Prehma 05-02748
FDA UDI
Class IActive
Diamond D 1013066
EUDAMEDFDA UDI
Class IIActive
Keystone Industries 1900770
FDA UDI
Class IActive
Versacryl 1014012
FDA UDI
Class IIActive
Bosworth Flexo 1662215
FDA UDI
Class IActive
Clearmet 1009225
FDA UDI
Class IIActive
Sledgehammer 1000523
FDA UDI
Class IIActive
Mizzy Millennium 1014351
FDA UDI
Class IIActive
Mizzy Fleck's 6070395
FDA UDI
Class IIActive
KeyPrint 4220141
FDA UDI
Class IActive
Mizzy Millennium 6010035
FDA UDI
Class IIActive
Prehma 05-08348
FDA UDI
Class IActive
Gelato 24-07577
EUDAMEDFDA UDI
Class IActive
Proform 9614780R1
EUDAMEDFDA UDI
Class IActive
Prehma 19-00412
FDA UDI
Class IActive
Prehma 05-10748
FDA UDI
Class IActive
Keystone Industries 1800086
FDA UDI
Class IActive
Sledgehammer 1000536
FDA UDI
Class IIActive
Prehma 05-19048
FDA UDI
Class IActive
Sledgehammer 1000521
FDA UDI
Class IIActive
Prehma 05-15948
FDA UDI
Class IActive
Mizzy Fleck's 6056700
FDA UDI
Class IIActive
Gelato 24-04077
FDA UDI
Class IActive
Prehma 05-10248
FDA UDI
Class IActive
Bosworth 16670N
FDA UDI
Class IActive
Omni 24-42941
FDA UDI
Class IActive
Versacryl 1014032
FDA UDI
Class IIActive
Diamond D 1013060
FDA UDI
Class IIActive
Proform 9614960R1
EUDAMEDFDA UDI
Class IActive
Mizzy Fleck's 6055700
FDA UDI
Class IIActive
Prehma 10-06010
FDA UDI
Class IActive
Mizzy Millennium 1014331
FDA UDI
Class IIActive
Proform 9597130R1
EUDAMEDFDA UDI
UActive
Sledgehammer 1000490
FDA UDI
Class IIActive
Proform 9603595R2
FDA UDI
UActive
Versacryl 1014014
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