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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 6 of 19

Device	Model / Reference	Registries	Class	Status
Optimus	19-SO9400	FDA UDI	Class I	Active
Mizzy Fleck's	6050100	FDA UDI	Class II	Active
Proflex	9146535	FDA UDI	Class II	Active
Bosworth Flexo	1662217	FDA UDI	Class I	Active
Prehma	03-20010	FDA UDI	Class I	Active
Proform	9614830R1	EUDAMEDFDA UDI	Class I	Active
Prehma	19-00712	FDA UDI	Class I	Active
Proform	9640966R2	EUDAMEDFDA UDI	Class I	Active
Mizzy Fleck's	6053900	FDA UDI	Class II	Active
Mizzy Fleck's	6055210	FDA UDI	Class II	Active
Prehma	05-12548	FDA UDI	Class I	Active
Keystone Industries	1900750	FDA UDI	Class I	Active
Proform	9603580R2	FDA UDI	U	Active
Bosworth	0921418	FDA UDI	Class I	Active
Mizzy Millennium	6010030	FDA UDI	Class II	Active
Gelato	24-03177	EUDAMEDFDA UDI	Class I	Active
Affordable	1014220	FDA UDI	Class II	Unknown
Diamond D	1013063	EUDAMEDFDA UDI	Class II	Active
KeyPrint	4220431	FDA UDI	Class II	Active
Prehma	05-06848	FDA UDI	Class I	Active
Keystone Industries	1271000	FDA UDI	Class I	Active
Mizzy Millennium	1014320	FDA UDI	Class II	Active
Seity	0702777	FDA UDI	Class II	Active
Prehma	05-53248	FDA UDI	Class I	Active
Proform	9614870	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	1271270	FDA UDI	Class I	Active
Prehma	05-13184	FDA UDI	Class I	Active
Pearson	7001284	FDA UDI	Class I	Active
Gelato	24-11477	FDA UDI	Class I	Active
Bosworth	0921484	FDA UDI	Class I	Active
Bosworth	16651	FDA UDI	Class I	Active
Optimize	00122	FDA UDI	Class I	Active
Proform	9614980	EUDAMEDFDA UDI	Class I	Active
Prehma	12-01010	FDA UDI	Class I	Active
Proform	9597090R2	FDA UDI	U	Active
American Dental	21-034	FDA UDI	Class I	Active
Bosworth	16691B	FDA UDI	Class I	Active
Prehma	05-53648	FDA UDI	Class I	Active
Affordable	1014230	FDA UDI	Class II	Unknown
Procure	9634740	FDA UDI	Class II	Active
Mizzy Comfort Cushion	6070115	FDA UDI	Class I	Active
Enamelite	5100182	FDA UDI	Class II	Unknown
Prehma	05-00348	FDA UDI	Class I	Active
Prehma	05-60148	FDA UDI	Class I	Active
Mizzy Comfort Cushion	6070140	FDA UDI	Class I	Active
Sledgehammer	1000497	FDA UDI	Class II	Active
Proform	9615058	EUDAMEDFDA UDI	Class I	Active
Prehma	05-81348	FDA UDI	Class I	Active
Pearson	7000877	FDA UDI	Class I	Active
Bosworth	16670R	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