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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 8 of 19

Device	Model / Reference	Registries	Class	Status
KeyPrint	4220433	FDA UDI	Class II	Active
Keystone Industries	1810035	FDA UDI	Class I	Active
Mizzy Millennium	1014361	FDA UDI	Class II	Active
Keystone Industries	7000310	FDA UDI	Class I	Active
Mizzy Fleck's	6051300	FDA UDI	Class II	Active
Sledgehammer	1000484	FDA UDI	Class II	Active
Prehma	05-81148	FDA UDI	Class I	Active
Seity	0700377	FDA UDI	Class II	Active
Keystone Industries	1900740	FDA UDI	Class I	Active
Sledgehammer	1000502	FDA UDI	Class II	Active
Pure Life	24-42683	FDA UDI	Class I	Active
Proform	9614840	EUDAMEDFDA UDI	Class I	Active
Diamond D	1013061	EUDAMEDFDA UDI	Class II	Active
Versacryl	1014013	FDA UDI	Class II	Active
Omni	24-42940	FDA UDI	Class I	Active
Prehma	05-00148	FDA UDI	Class I	Active
Mizzy Fleck's	6050500	FDA UDI	Class II	Unknown
Keystone Industries	1271250	FDA UDI	Class I	Active
Diamond D	1013040	EUDAMEDFDA UDI	Class II	Active
Keystone Industries	1800050	FDA UDI	Class I	Active
Mizzy Fleck's	6050400	FDA UDI	Class II	Active
Diamond D	1013101	FDA UDI	Class II	Active
Diamond D	1013064	EUDAMEDFDA UDI	Class II	Active
Prehma	19-00112	FDA UDI	Class I	Active
Pearson	7001280	FDA UDI	Class I	Active
Keystone Industries	1271120	FDA UDI	Class I	Active
Prehma	05-62448	FDA UDI	Class I	Active
Versacryl	1014024	FDA UDI	Class II	Active
Prehma	05-60248	FDA UDI	Class I	Active
Prehma	05-61148	FDA UDI	Class I	Active
Prehma	05-50448	FDA UDI	Class I	Active
Keystone Industries	1900760	FDA UDI	Class I	Active
Diamond D	1013082	FDA UDI	Class II	Active
Gelato	24-03977	FDA UDI	Class I	Active
Proform	9615025R2	FDA UDI	Class I	Active
i-Smile	01601	FDA UDI	Class I	Active
Bosworth	16691	FDA UDI	Class I	Active
Prehma	10-04510	FDA UDI	Class I	Active
Prehma	19-00512	FDA UDI	Class I	Active
Prehma	05-62848	FDA UDI	Class I	Active
Diamond D	1014259	FDA UDI	Class II	Active
Enamelite	5100185	FDA UDI	Class II	Unknown
KeyPrint	4200431	FDA UDI	Class II	Active
Mizzy Millennium	1014326	FDA UDI	Class II	Active
Keystone HB VPS	6081712	FDA UDI	Class II	Active
Prehma	05-15648	FDA UDI	Class I	Active
Proform	9614790	EUDAMEDFDA UDI	Class I	Active
Sledgehammer	1000513	FDA UDI	Class II	Active
Sledgehammer	1000549	FDA UDI	Class II	Active
Versacryl	1014010	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