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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 9 of 19

Device	Model / Reference	Registries	Class	Status
Sledgehammer	1000472	FDA UDI	Class II	Active
Prehma	05-51048	FDA UDI	Class I	Active
Prehma	05-01648	FDA UDI	Class I	Active
Keystone Industries	1110010	FDA UDI	Class I	Active
Mizzy Comfort Cushion	6070120	FDA UDI	Class I	Active
Mizzy Comfort Cushion	6070130	FDA UDI	Class I	Active
Diamond D	1014253	EUDAMEDFDA UDI	Class II	Active
Diamond D	1013055	FDA UDI	Class II	Active
Proform	9614790R2	EUDAMEDFDA UDI	Class I	Active
Keystone HB VPS	6081711	FDA UDI	Class II	Active
Diamond D	1013111	FDA UDI	Class II	Active
Diamond D	1013109	FDA UDI	Class II	Active
Prehma	05-22948	FDA UDI	Class I	Active
Pure Life	24-42697	FDA UDI	Class I	Active
Bosworth	0921425	FDA UDI	Class I	Active
KeyPrint	4220001	EUDAMEDFDA UDI	Class I	Active
Sledgehammer	1001966	FDA UDI	Class II	Active
Keystone Industries	1271430	FDA UDI	Class I	Active
Bosworth	0921488	FDA UDI	Class I	Active
Proform	9640967	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	6010010	FDA UDI	Class II	Active
Omni	24-42945	FDA UDI	Class I	Active
Diamond D	1014257	FDA UDI	Class II	Active
Proform	9640964	FDA UDI	Class I	Active
Proform	9614960	EUDAMEDFDA UDI	Class I	Active
Prehma	05-15548	FDA UDI	Class I	Active
Keystone HB	6081105	FDA UDI	Class II	Active
Prehma	10-06310	FDA UDI	Class I	Active
Prehma	05-09348	FDA UDI	Class I	Active
Prehma	27-00210	FDA UDI	Class I	Active
Proflex	9146575	FDA UDI	Class II	Active
Keystone Industries	1271020	FDA UDI	Class I	Active
Mizzy Millennium	6010016	FDA UDI	Class II	Active
Keystone Industries	1271010	FDA UDI	Class I	Active
Proform	9640965R1	EUDAMEDFDA UDI	Class I	Active
Fortis	24-13377	FDA UDI	Class I	Active
Gelato	24-02377	EUDAMEDFDA UDI	Class I	Active
Mizzy Comfort Cushion	6070105	FDA UDI	Class I	Active
Bosworth Flexo	1662213	FDA UDI	Class I	Active
Proform	9614775	EUDAMEDFDA UDI	Class I	Active
Proform	9615025	FDA UDI	Class I	Active
Sledgehammer	1000478	FDA UDI	Class II	Active
Sledgehammer	1000479	FDA UDI	Class II	Active
Affordable	1014273	FDA UDI	Class II	Unknown
American Dental	21-006	FDA UDI	Class I	Active
Proform	9615000	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	6010032	FDA UDI	Class II	Active
Omni	24-42948	FDA UDI	Class I	Active
Pearson	7001278	FDA UDI	Class I	Active
Keystone Industries	1271240	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