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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 4 of 19
DeviceModel / ReferenceRegistriesClassStatus
Proform 9614985
FDA UDI
Class IActive
Mizzy Millennium 6010048
FDA UDI
Class IIActive
KeyMill 1009310
EUDAMEDFDA UDI
Class IIActive
Procure 9143240
FDA UDI
Class IIActive
Keystone HB 6081104
FDA UDI
Class IIActive
Prehma 19-00812
FDA UDI
Class IActive
ItsoClear 1009150M
FDA UDI
Class IActive
Mizzy 6070500
FDA UDI
Class IActive
Nero 9039855
FDA UDI
Class IActive
Proform 9615025R1
FDA UDI
Class IActive
Proform 9614825
EUDAMEDFDA UDI
Class IActive
Prehma 19-00612
FDA UDI
Class IActive
Enamelite 5100179
FDA UDI
Class IIActive
Prehma 05-26148
FDA UDI
Class IActive
Diamond D 1013068
FDA UDI
Class IIActive
Bosworth 16636
FDA UDI
Class IActive
Prehma 05-50548
FDA UDI
Class IActive
Enamelite 5100187
FDA UDI
Class IIUnknown
Proform 9603605R1
EUDAMEDFDA UDI
UActive
Bosworth 16670LB
FDA UDI
Class IActive
Proform 9604701R1
EUDAMEDFDA UDI
UActive
Pearson 7000871
FDA UDI
Class IActive
Keystone Industries 1271080
FDA UDI
Class IActive
Mizzy Comfort Cushion 6070160
FDA UDI
Class IActive
Bosworth 0921485
FDA UDI
Class IActive
Diamond D 1013074
FDA UDI
Class IIActive
Prehma 10-50510
FDA UDI
Class IIActive
Sledgehammer 1000470
FDA UDI
Class IIActive
Prehma 36-01122
FDA UDI
Class IActive
Prehma 05-09148
FDA UDI
Class IActive
Diamond D 1013032
EUDAMEDFDA UDI
Class IIActive
Prehma 05-63848
FDA UDI
Class IActive
Versacryl 1014039
FDA UDI
Class IIActive
Prehma 05-02648
FDA UDI
Class IActive
Bosworth 16696
FDA UDI
Class IActive
Proform 9603580
EUDAMEDFDA UDI
UActive
Mizzy Millennium 1014353
FDA UDI
Class IIActive
Diamond D 1013107
FDA UDI
Class IIActive
Pure Life 24-42692
FDA UDI
Class IActive
Mizzy Fleck's 6055600
FDA UDI
Class IIActive
Sledgehammer 1000514
FDA UDI
Class IIActive
Diamond D 1013099
FDA UDI
Class IIActive
Proform 9597130R2
FDA UDI
UActive
Sledgehammer 1000474
FDA UDI
Class IIActive
Keystone Industries 1110040
FDA UDI
Class IActive
Proform 9614810R2
EUDAMEDFDA UDI
Class IActive
Pearson 7001279
FDA UDI
Class IActive
Prehma 05-00248
FDA UDI
Class IActive
Sledgehammer 1000548
FDA UDI
Class IIActive
Mizzy Millennium 6010011
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