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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 12 of 19

Device	Model / Reference	Registries	Class	Status
Proform	9604700R2	EUDAMEDFDA UDI	U	Active
Enamelite	5100214	FDA UDI	Class II	Unknown
Diamond D	1014243	EUDAMEDFDA UDI	Class II	Active
Prehma	27-00110	FDA UDI	Class I	Active
Sledgehammer	1000494	FDA UDI	Class II	Active
Proform	9614980R2	EUDAMEDFDA UDI	Class I	Active
Bosworth	0921482	FDA UDI	Class I	Active
Simplastic	0921670	FDA UDI	Class I	Active
Prehma	05-01048	FDA UDI	Class I	Active
Proform	9615040R2	EUDAMEDFDA UDI	Class I	Active
Prehma	05-62148	FDA UDI	Class I	Active
Prehma	10-50310	FDA UDI	Class II	Active
Prehma	7902000	FDA UDI	Class I	Active
Prehma	05-23148	FDA UDI	Class I	Active
Prehma	05-02148	FDA UDI	Class I	Active
Bosworth	0921423	FDA UDI	Class I	Active
Prehma	10-04710	FDA UDI	Class I	Active
Prehma	05-00648	FDA UDI	Class I	Active
Proform	9614820	EUDAMEDFDA UDI	Class I	Active
Simplastic	0921672	FDA UDI	Class I	Active
Prehma	05-00748	FDA UDI	Class I	Active
Keystone Industries	1810050	FDA UDI	Class I	Active
Sledgehammer	1001973	FDA UDI	Class II	Active
Pearson	7000872	FDA UDI	Class I	Active
Prehma	05-03348	FDA UDI	Class I	Active
Diamond D	1013054	FDA UDI	Class II	Active
Diamond D	1014215	EUDAMEDFDA UDI	Class II	Active
Keystone Industries	1271310	FDA UDI	Class I	Active
Proform	9614800	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	1270010	FDA UDI	Class I	Active
Prehma	05-80548	FDA UDI	Class I	Active
Mizzy Millennium	6010034	FDA UDI	Class II	Active
Prehma	05-08948	FDA UDI	Class I	Active
Diamond D	1013093	FDA UDI	Class II	Active
Gelato	24-16577	FDA UDI	Class I	Active
Sledgehammer	1000591	FDA UDI	Class II	Active
Mizzy Millennium	1014310	FDA UDI	Class II	Active
Enamelite	5100186	FDA UDI	Class II	Unknown
Proform	7000191	EUDAMEDFDA UDI	U	Active
Mizzy Millennium	6010045	FDA UDI	Class II	Active
Proform	9604700	EUDAMEDFDA UDI	U	Active
Keystone Industries	1270020	FDA UDI	Class I	Active
Mizzy Millennium	6010020	FDA UDI	Class II	Active
Proform	9597150	EUDAMEDFDA UDI	Class I	Active
Proform	9614850R1	EUDAMEDFDA UDI	Class I	Active
Prehma	05-02948	FDA UDI	Class I	Active
Sledgehammer	1000477	FDA UDI	Class II	Active
Mizzy Comfort Cushion	6070170	FDA UDI	Class I	Active
Keystone Industries	1900790	FDA UDI	Class I	Active
Gelato	24-03077	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