Is this your brand? Sign in to claim ownership.

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 1 of 19

Device	Model / Reference	Registries	Class	Status
Pro-Form Soft EVA	9597240R2PP	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597040PP	EUDAMED	Class I	Active
Nightguards	9602550R2	EUDAMED	Class I	Active
Blue Tray Material	9617410R1	EUDAMED	Class I	Active
Pro-Form Splint Material	9614860R1	EUDAMED	Class I	Active
KeySplint Soft Clear for Carbon Printers	4210155	EUDAMED	Class IIa	Active
Blue Tray Material	9617360	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597040R2PP	EUDAMED	Class I	Active
Nightguards	9602550R1	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597130R2PP	EUDAMED	Class I	Active
Blue Tray Material	9617350	EUDAMED	Class I	Active
KeySplint Ultra Hard Clear	4220162	EUDAMED	Class IIa	Active
Pro-Form Soft EVA	9597040R1PP	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597130PP	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597240R1PP	EUDAMED	Class I	Active
Mizzy Pressure Indicating Paste	6121000	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597130R21	EUDAMED	Class I	Active
Mizzy Pressure Indicating Paste	6120220	EUDAMED	Class I	Active
KeySplint Ultra Soft Clear	4220170	EUDAMED	Class IIa	Active
Pro-Form Soft EVA	9597130R1PP	EUDAMED	Class I	Active
Pro-Form Soft EVA	9597240PP	EUDAMED	Class I	Active
Pro-Form EVA Plus	7000191PP	EUDAMED	Class I	Active
Tray Aways	0921888	EUDAMED	Class I	Active
Blue Tray Material	9617410	EUDAMED	Class I	Active
Pro-Form EVA Plus	7000191R2PP	EUDAMED	Class I	Active
Diamond D Ultra Impact Denture Acrylic	1013015	EUDAMED	Class IIa	Active
KeySplint Soft Blue	4220175	EUDAMED	Class IIa	Active
Keystone Industries	1271230	FDA UDI	Class I	Active
Mizzy Fleck's	6050200	FDA UDI	Class II	Active
Prehma	05-00848	FDA UDI	Class I	Active
Keystone Industries	1810045	FDA UDI	Class I	Active
Proform	9603605	EUDAMEDFDA UDI	U	Active
Proform	9597150R2	EUDAMEDFDA UDI	U	Active
Sledgehammer	1000483	FDA UDI	Class II	Active
Prehma	05-09448	FDA UDI	Class I	Active
Proform	9614956	EUDAMEDFDA UDI	Class I	Active
Proform	9614875	FDA UDI	Class I	Active
Sledgehammer	1000499	FDA UDI	Class II	Active
Pearson	7000957	FDA UDI	Class I	Active
Prehma	05-18648	FDA UDI	Class I	Active
Enamelite	5100188	FDA UDI	Class II	Unknown
Simplastic	0921661	FDA UDI	Class I	Active
Keystone Industries	1900730	FDA UDI	Class I	Active
Sledgehammer	1000512	FDA UDI	Class II	Active
KeyPrint	4220406	FDA UDI	Class I	Active
Mizzy Millennium	6010039	FDA UDI	Class II	Active
Sledgehammer	1000476	FDA UDI	Class II	Active
Gelato	24-09077	FDA UDI	Class I	Active
Bosworth	0921417	FDA UDI	Class I	Active
Fortis	24-13177	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