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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 13 of 19

Device	Model / Reference	Registries	Class	Status
Keystone Industries	1810070	FDA UDI	Class I	Active
Gelato	24-15977	FDA UDI	Class I	Active
i-Smile	01600	FDA UDI	Class I	Active
Gelato	24-02977	FDA UDI	Class I	Active
Prehma	1018210	FDA UDI	Class II	Unknown
Mizzy Millennium	1014335	FDA UDI	Class II	Active
Diamond D	1013056	FDA UDI	Class II	Active
Sledgehammer	1000516	FDA UDI	Class II	Active
Proflex	9641000	FDA UDI	Class II	Active
Proflex	9146485	FDA UDI	Class II	Active
Carbon	4220442	FDA UDI	Class II	Active
Keystone Industries	1800035	FDA UDI	Class I	Active
Sledgehammer	1001972	FDA UDI	Class II	Active
Procure	9143160	FDA UDI	Class II	Unknown
Affordable	1014232	FDA UDI	Class II	Unknown
Affordable	1014237	FDA UDI	Class II	Unknown
Proform	9602550	EUDAMEDFDA UDI	U	Active
Mizzy Millennium	1014332	FDA UDI	Class II	Active
Proform	9603590	FDA UDI	U	Active
KeyPrint	4200012	FDA UDI	N/A	Active
Keystone HB VPS	6081710	FDA UDI	Class II	Active
Keystone Industries	1270005	FDA UDI	Class I	Active
Pure Life	24-42689	FDA UDI	Class I	Active
Versacryl	1014023	FDA UDI	Class II	Active
Pure Life	24-42688	FDA UDI	Class I	Active
Prehma	05-09248	FDA UDI	Class I	Active
Diamond D	1013030	EUDAMEDFDA UDI	Class II	Active
Nero	9539170	FDA UDI	Class I	Active
Cora-Caine	16621	FDA UDI	Class I	Active
Proform	9614950	EUDAMEDFDA UDI	Class I	Active
Bosworth	16690	FDA UDI	Class I	Active
Proform	9640963R1	FDA UDI	Class I	Active
Proform	9604701R2	EUDAMEDFDA UDI	U	Active
Keystone HB	6081950	FDA UDI	Class II	Active
KeyPrint	4220151	EUDAMEDFDA UDI	U	Active
Prehma	05-61948	FDA UDI	Class I	Active
Keystone Industries	7000311	FDA UDI	Class I	Active
Mizzy Millennium	6010040	FDA UDI	Class II	Active
Diamond D	1013092	EUDAMEDFDA UDI	Class II	Active
Keystone Industries	7001417	FDA UDI	Class I	Active
KeyPrint	4220011	FDA UDI	Class II	Active
Bosworth	16670B	FDA UDI	Class I	Active
Mizzy Millennium	1014363	FDA UDI	Class II	Active
Diamond D	1014282	EUDAMEDFDA UDI	Class II	Active
Mizzy Fleck's	6055800	FDA UDI	Class II	Active
Diamond D	1013079	FDA UDI	Class II	Active
Proform	9597240R2	EUDAMEDFDA UDI	U	Active
Diamond D	1013094	FDA UDI	Class II	Active
Diamond D	1014244	EUDAMEDFDA UDI	Class II	Active
Mizzy Millennium	1014350	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