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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 14 of 19

Device	Model / Reference	Registries	Class	Status
Proform	7000191R1	EUDAMEDFDA UDI	Class I	Active
Diamond D	1013058	FDA UDI	Class II	Active
Diamond D	1013075	FDA UDI	Class II	Active
KeyPrint	4200010	FDA UDI	N/A	Active
Gelato	24-02677	EUDAMEDFDA UDI	Class I	Active
Mizzy Consistency	6081300	FDA UDI	Class II	Active
Bosworth	0921419	FDA UDI	Class I	Active
Versacryl	1014021	FDA UDI	Class II	Active
Prehma	05-00448	FDA UDI	Class I	Active
Proflex	9146551	FDA UDI	Class II	Active
Carbon	4220441	FDA UDI	Class II	Active
Enamelite	5100183	FDA UDI	Class II	Unknown
Proform	9615060R2	EUDAMEDFDA UDI	Class I	Active
Proform	9603580R1	EUDAMEDFDA UDI	U	Active
Affordable	1014211	FDA UDI	Class II	Unknown
Proform	9597040	EUDAMEDFDA UDI	Class I	Active
Sledgehammer	1001975	FDA UDI	Class II	Active
Prehma	12-01210	FDA UDI	Class I	Active
Keystone Industries	1900720	FDA UDI	Class I	Active
Proform	9614975	EUDAMEDFDA UDI	Class I	Active
Prehma	05-62248	FDA UDI	Class I	Active
Optimus	19-SO9600	FDA UDI	Class I	Active
Proform	9614830R2	EUDAMEDFDA UDI	Class I	Active
Prehma	05-67848	FDA UDI	Class I	Active
Keystone Industries	1271070	FDA UDI	Class I	Active
Proform	9640995R1	FDA UDI	Class I	Active
Diamond D	1013110	FDA UDI	Class II	Active
Proform	9614800R1	EUDAMEDFDA UDI	Class I	Active
Proflex	9146540	FDA UDI	Class II	Unknown
Keystone Industries	1271030	FDA UDI	Class I	Active
Bosworth	0921486	FDA UDI	Class I	Active
Pearson	7000874	FDA UDI	Class I	Active
Mizzy Millennium	1014311	FDA UDI	Class II	Active
Prehma	05-53348	FDA UDI	Class I	Active
Sledgehammer	1000539	FDA UDI	Class II	Active
Sledgehammer	1000475	FDA UDI	Class II	Active
Proform	9597240	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	1014330	FDA UDI	Class II	Active
Proform	9614790R1	EUDAMEDFDA UDI	Class I	Active
Proform	9596980R1	FDA UDI	U	Active
Versacryl	1014022	FDA UDI	Class II	Active
Prehma	19-02212	FDA UDI	Class I	Active
Mizzy Comfort Cushion	6070135	FDA UDI	Class I	Active
Prehma	05-11648	FDA UDI	Class I	Active
Clearmet	1009227	FDA UDI	Class II	Active
Prehma	05-53448	FDA UDI	Class I	Active
Gelato	24-02877	EUDAMEDFDA UDI	Class I	Active
Keystone Industries	7000305	FDA UDI	Class I	Active
Gelato	24-08077	FDA UDI	Class I	Active
Mizzy Millennium	1014321	FDA UDI	Class II	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