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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 18 of 19

Device	Model / Reference	Registries	Class	Status
Mizzy Fleck's	6050900	FDA UDI	Class II	Unknown
Prehma	05-05048	FDA UDI	Class I	Active
Sledgehammer	1000488	FDA UDI	Class II	Active
Pure Life	24-42693	FDA UDI	Class I	Active
Sledgehammer	1000485	FDA UDI	Class II	Active
Omni	24-42942	FDA UDI	Class I	Active
Prehma	05-14648	FDA UDI	Class I	Active
Mizzy Millennium	6010026	FDA UDI	Class II	Active
Prehma	05-26748	FDA UDI	Class I	Active
Mizzy Millennium	6010002	FDA UDI	Class II	Active
Prehma	19-00212	FDA UDI	Class I	Active
Sledgehammer	1000546	FDA UDI	Class II	Active
Sledgehammer	1000509	FDA UDI	Class II	Active
Fortis	24-13277	FDA UDI	Class I	Active
Prehma	05-02848	FDA UDI	Class I	Active
Proflex	9146510	FDA UDI	Class II	Unknown
Prehma	05-50848	FDA UDI	Class I	Active
Prehma	05-01348	FDA UDI	Class I	Active
American Dental	21-005	FDA UDI	U	Active
Bosworth	16692	FDA UDI	Class I	Active
Bosworth	16632	FDA UDI	Class I	Active
Mizzy Consistency	6081400	FDA UDI	Class II	Active
Prehma	05-14748	FDA UDI	Class I	Active
Procure	9143210	FDA UDI	Class II	Active
Bosworth	0921426	FDA UDI	Class I	Active
KeySplint Soft for HeyGears	4220115	EUDAMEDFDA UDI	Class I	Active
Mizzy Millennium	6010003	FDA UDI	Class II	Active
Prehma	1018010	FDA UDI	Class II	Unknown
Optimize	00139	FDA UDI	Class I	Active
Bosworth	0921489	FDA UDI	Class I	Active
American Dental	21-024	FDA UDI	Class I	Active
Bosworth Flexo	1662216	FDA UDI	Class I	Active
Prehma	05-62648	FDA UDI	Class I	Active
Versacryl	1014016	FDA UDI	Class II	Active
Prehma	05-11148	FDA UDI	Class I	Active
Bosworth Flexo	1662214	FDA UDI	Class I	Active
Prehma	05-50748	FDA UDI	Class I	Active
Prehma	05-08448	FDA UDI	Class I	Active
Prehma	05-10148	FDA UDI	Class I	Active
Mizzy Millennium	6010028	FDA UDI	Class II	Active
Prehma	05-51248	FDA UDI	Class I	Active
Prehma	05-07248	FDA UDI	Class I	Active
Gelato Prophy Paste	24-02277	EUDAMEDFDA UDI	Class I	Active
KeyTray	4200007	EUDAMED	Class I	Active
Fp3d	K250489	FDA 510(k)	Class II	Active
KeyPrint KeyDenture Base	K241089	FDA 510(k)	Class II	Active
KeyPrint KeySplint Soft	K183598	FDA 510(k)	U	Active
KeyGuide	4200001	EUDAMEDFDA UDI	Class I	Active
Tray Aways	0921884	EUDAMED	Class I	Active
Mizzy Pressure Indicating Paste	6120200	EUDAMED	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