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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 17 of 19

Device	Model / Reference	Registries	Class	Status
Mizzy Millennium	1014336	FDA UDI	Class II	Active
Pure Life	24-42696	FDA UDI	Class I	Active
Prehma	05-09548	FDA UDI	Class I	Active
Prehma	05-51648	FDA UDI	Class I	Active
Diamond D	1013017	FDA UDI	Class II	Active
Diamond D	1013059	FDA UDI	Class II	Active
Proflex	9640360	FDA UDI	Class I	Active
KeyPrint	4220430	FDA UDI	Class II	Active
Keystone Industries	1271220	FDA UDI	Class I	Active
Enamelite	5100191	FDA UDI	Class II	Unknown
Sledgehammer	1000498	FDA UDI	Class II	Active
Sledgehammer	1000495	FDA UDI	Class II	Active
Prehma	05-19548	FDA UDI	Class I	Active
Diamond D	1014252	EUDAMEDFDA UDI	Class II	Active
Prehma	10-05010	FDA UDI	Class I	Active
Proflex	9146390	FDA UDI	Class II	Active
Proflex	9146570	FDA UDI	Class II	Active
Prehma	05-11748	FDA UDI	Class I	Active
Prehma	05-14148	FDA UDI	Class I	Active
Sky Dental	SKY002	FDA UDI	Class I	Active
Proform	9640963	FDA UDI	Class I	Active
Proform	9596980R2	EUDAMEDFDA UDI	U	Active
Diamond D	1014216	EUDAMEDFDA UDI	Class II	Active
Versacryl	1014031	FDA UDI	Class II	Active
Bosworth	16652	FDA UDI	Class I	Active
Proform	9640968	FDA UDI	Class I	Active
Prehma	12-00210	FDA UDI	Class I	Active
Bosworth	0921483	FDA UDI	Class I	Active
Affordable	1014231	FDA UDI	Class II	Unknown
Sledgehammer	1000508	FDA UDI	Class II	Active
Mizzy Fleck's	6053700	FDA UDI	Class II	Active
Prehma	05-63548	FDA UDI	Class I	Active
Omni	24-42946	FDA UDI	Class I	Active
KeyPrint	4220161	EUDAMEDFDA UDI	U	Active
Keystone Industries	1271110	FDA UDI	Class I	Active
Keystone HB VPS	6081707	FDA UDI	Class II	Active
Bosworth	16630	FDA UDI	Class I	Active
Procure	9143170	FDA UDI	Class II	Active
Sledgehammer	1001962	FDA UDI	Class II	Active
Prehma	1018510	FDA UDI	Class II	Unknown
Mizzy Millennium	1014374	FDA UDI	Class II	Active
Prehma	1018610	FDA UDI	Class II	Unknown
Prehma	10-50410	FDA UDI	Class II	Active
Prehma	03-20310	FDA UDI	Class I	Active
Prehma	05-14448	FDA UDI	Class I	Active
Prehma	1017110	FDA UDI	Class II	Unknown
Mizzy Millennium	1014352	FDA UDI	Class II	Active
Mizzy Millennium	6010031	FDA UDI	Class II	Active
Versacryl	1014018	FDA UDI	Class II	Active
Prehma	10-05210	FDA UDI	Class I	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