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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 5 of 19

Device	Model / Reference	Registries	Class	Status
Pure Life	24-42694	FDA UDI	Class I	Active
Simplastic	0921660	FDA UDI	Class I	Active
Proform	9614943	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	1800085	FDA UDI	Class I	Active
Pearson	7000944	FDA UDI	U	Active
Prehma	05-53948	FDA UDI	Class I	Active
KeyPrint	4200430	FDA UDI	Class II	Active
Bosworth	0921420	FDA UDI	Class I	Active
Proform	9614830	FDA UDI	Class I	Active
Pure Life	24-42691	FDA UDI	Class I	Active
Proform	9614803	FDA UDI	Class I	Active
Prehma	05-05848	FDA UDI	Class I	Active
Enamelite	5100196	FDA UDI	Class II	Unknown
Proform	9597130	EUDAMEDFDA UDI	Class I	Active
Prehma	10-05310	FDA UDI	Class I	Active
Diamond D	1013077	FDA UDI	Class II	Active
Prehma	05-06148	FDA UDI	Class I	Active
Keystone Industries	1110020	FDA UDI	Class I	Active
Mizzy Fleck's	6050300	FDA UDI	Class II	Active
Mizzy Millennium	1014362	FDA UDI	Class II	Active
Proform	9597090R1	EUDAMEDFDA UDI	Class I	Active
Prehma	05-61348	FDA UDI	Class I	Active
Proform	9640965R2	EUDAMEDFDA UDI	Class I	Active
Diamond D	1014266	FDA UDI	Class II	Active
KeyPrint	4200014	FDA UDI	Class I	Active
Proform	9640963R2	FDA UDI	Class I	Active
Keystone HB VPS	6081708	FDA UDI	Class II	Active
Diamond D	1013106	EUDAMEDFDA UDI	Class II	Active
Sledgehammer	1000489	FDA UDI	Class II	Active
Proflex	9146465	FDA UDI	Class II	Active
Diamond D	1014223	FDA UDI	Class II	Active
Prehma	05-62748	FDA UDI	Class I	Active
Proform	9640996	EUDAMEDFDA UDI	Class I	Active
Proform	9597040R2	EUDAMEDFDA UDI	Class I	Active
Proform	9614965	FDA UDI	Class I	Active
Mizzy Consistency	6081600	FDA UDI	Class II	Active
Prehma	03-20210	FDA UDI	Class I	Active
Sledgehammer	1000522	FDA UDI	Class II	Active
Sledgehammer	1000535	FDA UDI	Class II	Active
Mizzy Fleck's	6052700	FDA UDI	Class II	Active
Sledgehammer	1000515	FDA UDI	Class II	Active
Prehma	05-51448	FDA UDI	Class I	Active
American Dental	21-027	FDA UDI	Class I	Active
Versacryl	1014020	FDA UDI	Class II	Active
Diamond D	1014283	EUDAMEDFDA UDI	Class II	Active
Mizzy Millennium	6010019	FDA UDI	Class II	Active
Bosworth	0921424	FDA UDI	Class I	Active
Proform	9614880	EUDAMEDFDA UDI	Class I	Active
Proform	9640962	EUDAMEDFDA UDI	Class I	Active
Proform	9614850R2	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