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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 7 of 19

Device	Model / Reference	Registries	Class	Status
Proform	9604720	FDA UDI	U	Active
Prehma	19-02112	FDA UDI	Class I	Active
Diamond D	1014254	EUDAMEDFDA UDI	Class II	Active
Prehma	27-01310	FDA UDI	Class I	Active
Diamond D	1013097	FDA UDI	Class II	Active
Prehma	05-60048	FDA UDI	Class I	Active
Mizzy Millennium	6010008	FDA UDI	Class II	Active
Diamond D	1014224	FDA UDI	Class II	Active
Proform	9602555	EUDAMEDFDA UDI	U	Active
Mizzy Millennium	6010046	FDA UDI	Class II	Active
Prehma	10-05810	FDA UDI	Class I	Active
Proform	9597240R1	EUDAMEDFDA UDI	U	Active
Prehma	05-12748	FDA UDI	Class I	Active
Sledgehammer	1000510	FDA UDI	Class II	Active
Gelato	24-11277	FDA UDI	Class I	Active
Prehma	19-00312	FDA UDI	Class I	Active
Sledgehammer	1001963	FDA UDI	Class II	Active
Sledgehammer	1000486	FDA UDI	Class II	Active
Mizzy Comfort Cushion	6070155	FDA UDI	Class I	Active
Proform	9604700R1	EUDAMEDFDA UDI	U	Active
Diamond D	1013081	FDA UDI	Class II	Active
Sledgehammer	1000482	FDA UDI	Class II	Active
Bosworth	16653	FDA UDI	Class I	Active
Mizzy Millennium	6010042	FDA UDI	Class II	Active
Optimize	00157	FDA UDI	Class I	Active
Mizzy Millennium	6010018	FDA UDI	Class II	Active
KeyPrint	4200433	FDA UDI	Class II	Active
Mizzy Fleck's	6051700	FDA UDI	Class II	Active
Mizzy Millennium	6010007	FDA UDI	Class II	Active
Mizzy Millennium	6010006	FDA UDI	Class II	Active
Keystone Industries	1147577	FDA UDI	Class I	Active
Proform	9603595	EUDAMEDFDA UDI	U	Active
Proform	9640961R1	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	1900780	FDA UDI	Class I	Active
Bosworth	0921421	FDA UDI	Class I	Active
Fortis	24-13077	FDA UDI	Class I	Active
Simplastic	0921671	FDA UDI	Class I	Active
Prehma	05-62348	FDA UDI	Class I	Active
Keystone Industries	1271500	FDA UDI	Class I	Active
Proform	9603640	FDA UDI	U	Active
Affordable	1014226	FDA UDI	Class II	Unknown
Prehma	10-06410	FDA UDI	Class I	Active
Diamond D	1013072	EUDAMEDFDA UDI	Class II	Active
Prehma	05-02348	FDA UDI	Class I	Active
iSmile	0701377	FDA UDI	Class II	Active
Keystone Industries	1271050	FDA UDI	Class I	Active
Sledgehammer	1001965	FDA UDI	Class II	Active
Bosworth	0921867	FDA UDI	Class I	Active
Proform	9614880R1	EUDAMEDFDA UDI	Class I	Active
Proform	9640961	EUDAMEDFDA 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