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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 11 of 19

Device	Model / Reference	Registries	Class	Status
Omni	24-42943	FDA UDI	Class I	Active
Pure Life	24-42690	FDA UDI	Class I	Active
Proform	9614850	EUDAMEDFDA UDI	Class I	Active
Pearson	7000913	FDA UDI	Class I	Active
Mizzy Consistency	6081200	FDA UDI	Class II	Active
Prehma	05-51548	FDA UDI	Class I	Active
Prehma	05-19148	FDA UDI	Class I	Active
Diamond D	1013103	FDA UDI	Class II	Active
Mizzy Consistency	6081500	FDA UDI	Class II	Active
Proform	9640964R2	FDA UDI	Class I	Active
Mizzy Fleck's	6053800	FDA UDI	Class II	Active
Versacryl	1014033	FDA UDI	Class II	Active
KeyMill	1009311	EUDAMEDFDA UDI	Class II	Active
Mizzy Consistency	6081700	FDA UDI	Class II	Active
Diamond D	1013026	EUDAMEDFDA UDI	Class II	Active
Keystone Industries	1110030	FDA UDI	Class I	Active
Proform	9614820R1	EUDAMEDFDA UDI	Class I	Active
Prehma	05-15248	FDA UDI	Class I	Active
Sledgehammer	1000541	FDA UDI	Class II	Active
Gelato	24-11177	FDA UDI	Class I	Active
Proform	7000191R2	FDA UDI	U	Active
Proform	9604701	EUDAMEDFDA UDI	U	Active
Mizzy Millennium	1014337	FDA UDI	Class II	Active
Diamond D	1013073	FDA UDI	Class II	Active
Proform	9614811	FDA UDI	Class I	Active
Diamond D	1014242	EUDAMEDFDA UDI	Class II	Active
Sledgehammer	1000590	FDA UDI	Class II	Active
Proform	9603605R2	EUDAMEDFDA UDI	U	Active
Proform	9615000R1	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	1014360	FDA UDI	Class II	Active
Versacryl	1014017	FDA UDI	Class II	Active
Proform	9614960R2	EUDAMEDFDA UDI	Class I	Active
Mizzy Comfort Cushion	6070165	FDA UDI	Class I	Active
Prehma	05-08148	FDA UDI	Class I	Active
Diamond D	1013100	FDA UDI	Class II	Active
Gelato	24-05077	EUDAMEDFDA UDI	Class I	Active
Diamond D	1013052	FDA UDI	Class II	Active
Prehma	05-53848	FDA UDI	Class I	Active
Versacryl	1014019	FDA UDI	Class II	Active
Proform	9615020R2	EUDAMEDFDA UDI	Class I	Active
Keystone HB VPS	6081709	FDA UDI	Class II	Active
Mizzy Millennium	1014342	FDA UDI	Class II	Active
KeyPrint	4200432	FDA UDI	Class II	Active
Gelato	24-02477	EUDAMEDFDA UDI	Class I	Active
Diamond D	1013051	FDA UDI	Class II	Active
KeyPrint	4220155	EUDAMEDFDA UDI	Class I	Active
Prehma	10-05110	FDA UDI	Class I	Active
Mizzy Millennium	6010049	FDA UDI	Class II	Active
Enamelite	5100197	FDA UDI	Class II	Unknown
Pearson	7001276	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