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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 15 of 19

Device	Model / Reference	Registries	Class	Status
Prehma	05-51348	FDA UDI	Class I	Active
Diamond D	1013116	FDA UDI	Class II	Active
Nexa3D	4250205	FDA UDI	Class I	Active
Prehma	05-11048	FDA UDI	Class I	Active
Enamelite	5100181	FDA UDI	Class II	Active
Proform	9640995R2	EUDAMEDFDA UDI	Class I	Active
Proform	9597090	EUDAMEDFDA UDI	Class I	Active
Prehma	05-50948	FDA UDI	Class I	Active
Versacryl	1014025	FDA UDI	Class II	Active
Mizzy Millennium	6010014	FDA UDI	Class II	Active
Sledgehammer	1000545	FDA UDI	Class II	Active
Prehma	05-00948	FDA UDI	Class I	Active
Prehma	12-00110	FDA UDI	Class I	Active
Diamond D	1013050	FDA UDI	Class II	Active
Prehma	7003999	FDA UDI	Class I	Active
Keystone Industries	7000314	FDA UDI	Class I	Active
Keystone Industries	7000811	FDA UDI	Class I	Active
Omni	24-42944	FDA UDI	Class I	Active
Diamond D	1013078	FDA UDI	Class II	Active
Prehma	1017010	FDA UDI	Class II	Unknown
Bosworth	0921481	FDA UDI	Class I	Active
Proflex	9146490	FDA UDI	Class II	Unknown
Mizzy	6070510	FDA UDI	Class I	Active
Clearmet	1009229	FDA UDI	Class II	Active
Mizzy Consistency	6081000	FDA UDI	Class II	Active
Optimize	00158	FDA UDI	Class I	Active
Proform	9614810R1	EUDAMEDFDA UDI	Class I	Active
Prehma	05-00548	FDA UDI	Class I	Active
Gelato	24-02777	EUDAMEDFDA UDI	Class I	Active
Proform	9640968R2	FDA UDI	Class I	Active
Pearson	7000878	FDA UDI	Class I	Active
Keystone Industries	1271040	FDA UDI	Class I	Active
Sledgehammer	1001961	FDA UDI	Class II	Active
Proform	9615060	EUDAMEDFDA UDI	Class I	Active
Keystone HB	6081816	FDA UDI	Class II	Active
Proform	9615060R1	EUDAMEDFDA UDI	Class I	Active
KeyPrint	4200161	FDA UDI	U	Active
Proform	9640966R1	EUDAMEDFDA UDI	Class I	Active
KeyPrint	4200011	EUDAMEDFDA UDI	Class II	Active
Prehma	05-02548	FDA UDI	Class I	Active
Sledgehammer	1001971	FDA UDI	Class II	Active
KeyMill	1009313	EUDAMEDFDA UDI	Class II	Active
Prehma	36-01022	FDA UDI	Class I	Active
Affordable	1014236	FDA UDI	Class II	Unknown
Proform	9614795	EUDAMEDFDA UDI	Class I	Active
Proform	9614780R2	EUDAMEDFDA UDI	Class I	Active
Versacryl	1014015	FDA UDI	Class II	Active
Proform	9640965	EUDAMEDFDA UDI	Class I	Active
Prehma	27-00310	FDA UDI	Class I	Active
Proform	9603595R1	FDA UDI	U	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