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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 10 of 19
DeviceModel / ReferenceRegistriesClassStatus
Diamond D 1014284
EUDAMEDFDA UDI
Class IIActive
Sledgehammer 1000487
FDA UDI
Class IIActive
Prehma 05-62548
FDA UDI
Class IActive
Simplastic 0921662
FDA UDI
Class IActive
Sledgehammer 1000543
FDA UDI
Class IIActive
Sledgehammer 1000503
FDA UDI
Class IIActive
Prehma 05-50248
FDA UDI
Class IActive
Diamond D 1014258
FDA UDI
Class IIActive
Bosworth Flexo 1662218
FDA UDI
Class IActive
Diamond D 1013024
EUDAMEDFDA UDI
Class IIActive
Mizzy Consistency 6081100
FDA UDI
Class IIActive
Gelato 24-10877
FDA UDI
Class IActive
Proform 9597035
EUDAMEDFDA UDI
UActive
Enamelite 5100184
FDA UDI
Class IIUnknown
Sledgehammer 1000473
FDA UDI
Class IIActive
Keystone Industries 7000313
FDA UDI
Class IActive
Mizzy Millennium 6010004
FDA UDI
Class IIActive
Prehma 05-04248
FDA UDI
Class IActive
KeyPrint 4220432
FDA UDI
Class IIActive
Bosworth Flexo 1662219
FDA UDI
Class IActive
Pure Life 24-42695
FDA UDI
Class IActive
Mizzy Fleck's 6055900
FDA UDI
Class IIActive
M&S 0702177
FDA UDI
Class IIActive
Sledgehammer 1000540
FDA UDI
Class IIActive
Prehma 03-20110
FDA UDI
Class IActive
Proform 9615020
EUDAMEDFDA UDI
Class IActive
Mizzy Comfort Cushion 6070125
FDA UDI
Class IActive
Prehma 12-01110
FDA UDI
Class IActive
Nexa3D 4250204
FDA UDI
Class IIActive
Prehma 05-06648
FDA UDI
Class IActive
KeyPrint 4200155
EUDAMEDFDA UDI
UActive
Prehma 05-04148
FDA UDI
Class IActive
Proform 9640995
EUDAMEDFDA UDI
Class IActive
Prehma 05-80448
FDA UDI
Class IActive
Sledgehammer 1000517
FDA UDI
Class IIActive
Prehma 05-62048
FDA UDI
Class IActive
Versacryl 1014034
FDA UDI
Class IIActive
Prehma 05-14548
FDA UDI
Class IActive
Pure Life 24-42684
FDA UDI
Class IActive
Prehma 05-10948
FDA UDI
Class IActive
Prehma 19-02012
FDA UDI
Class IActive
KeyPrint 50522-01
FDA UDI
Class IActive
KeyPrint 4200434
FDA UDI
Class IIActive
American Dental 21-004
FDA UDI
Class IActive
Diamond D 1013067
EUDAMEDFDA UDI
Class IIActive
Proform 9597150R1
EUDAMEDFDA UDI
Class IActive
Mizzy Comfort Cushion 6070110
FDA UDI
Class IActive
Prehma 27-00510
FDA UDI
Class IActive
Proform 9614980R1
EUDAMEDFDA UDI
Class IActive
Versacryl 1014026
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