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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 3 of 19

Device	Model / Reference	Registries	Class	Status
Proform	9614785	FDA UDI	Class I	Active
Pearson	7000873	FDA UDI	Class I	Active
Proform	9640967R2	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	6010015	FDA UDI	Class II	Active
Prehma	1018410	FDA UDI	Class II	Unknown
Proform	9597040R1	EUDAMEDFDA UDI	U	Active
Prehma	05-51148	FDA UDI	Class I	Active
Sledgehammer	1000518	FDA UDI	Class II	Active
Mizzy Fleck's	6053600	FDA UDI	Class II	Active
Proform	9596980	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	1271090	FDA UDI	Class I	Active
Proform	9640961R2	EUDAMEDFDA UDI	Class I	Active
KeyPrint	4220008	EUDAMEDFDA UDI	Class I	Active
Omni	24-42947	FDA UDI	Class I	Active
Prehma	05-01448	FDA UDI	Class I	Active
Keystone Industries	1271060	FDA UDI	Class I	Active
Prehma	10-05610	FDA UDI	Class I	Active
Proform	9614800R2	EUDAMEDFDA UDI	Class I	Active
Optimize	00163	FDA UDI	Class I	Active
American Dental	21-025	FDA UDI	Class I	Active
Proform	9603630	FDA UDI	U	Active
Prehma	05-26048	FDA UDI	Class I	Active
Diamond D	1013083	FDA UDI	Class II	Active
Proform	9614810	FDA UDI	Class I	Active
Bosworth	0921480	FDA UDI	Class I	Active
Proform	9614880R2	EUDAMEDFDA UDI	Class I	Active
Pure Life	24-42685	FDA UDI	Class I	Active
Keystone Industries	7000306	FDA UDI	Class I	Active
Keystone Industries	1800025	FDA UDI	Class I	Active
Proflex	9146200	FDA UDI	Class II	Active
Mizzy Fleck's	6051400	FDA UDI	Class II	Active
Keystone Industries	7000312	FDA UDI	Class I	Active
KeySplint Soft for EnvisionTEC	4220105	EUDAMEDFDA UDI	U	Active
Mizzy Millennium	6010043	FDA UDI	Class II	Active
Procure	9143100	FDA UDI	Class II	Active
Diamond D	1014264	FDA UDI	Class II	Active
Prehma	05-05748	FDA UDI	Class I	Active
KeyPrint	4220434	FDA UDI	Class II	Active
Prehma	05-06948	FDA UDI	Class I	Active
Proform	9614840R1	EUDAMEDFDA UDI	Class I	Active
Proform	9615020R1	EUDAMEDFDA UDI	Class I	Active
Prehma	05-01248	FDA UDI	Class I	Active
HeyGears	4220114	FDA UDI	Class II	Active
Prehma	05-64648	FDA UDI	Class I	Active
Mizzy Millennium	6010027	FDA UDI	Class II	Active
KeyPrint	4200406	EUDAMEDFDA UDI	Class I	Active
Prehma	05-01548	FDA UDI	Class I	Active
Sledgehammer	1000496	FDA UDI	Class II	Active
Proflex	9146430	FDA UDI	Class II	Active
Diamond D	1014225	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

KEYSTONE Europe BV NL
MDSS GmbH DE

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.

Date	Recall No.	Class	Status	Reason
Nov 20, 2023	Z-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, 2023	Z-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, 2023	Z-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