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Keystone Industries

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000020203 FEI 2523320

Keystone Industries is a medical device manufacturer based in the United States, with 941 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I, Class II and Unclassified; EU Class I) and 3 FDA recalls as of 12 Nov 2026.

Devices
941
Registrations
EUDAMEDFDA
FDA recalls
33 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 880
  • EUDAMED 248
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class I 485
  • FDA Class II 341
  • EU Class I 60
  • FDA Unclassified 44
  • EU Class IIa 9
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000020203
  • FDA FEI 2523320
  • DUNS 073503117

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls
Authorised rep.
KEYSTONE Europe BVNL
Authorised rep.
MDSS GmbHDE

What Keystone Industries makes

Keystone Industries manufactures dental materials and tools, including resin and thermoplastic fabrication materials for appliances like nightguards and splints, reusable carbide dental burs, single-use dental wedges and suction cannulas, zinc phosphate cement, and preformed metal denture clasps. Their product line also covers dentifrice and specialized tray materials for dental impressions.

The company’s devices are classified under FDA’s Class I, Class II, Class IIa, and unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database and the EU’s EUDAMED registry. Keystone Industries is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue941

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000020203
FDA FEI number
2523320
DUNS number
073503117
EUDAMED status
Active
EUDAMED registered name
Keystone Industries
EUDAMED abbreviated name
Keystone Industries
Registered address
52, West King Street, 17067, Myerstown, PA, United States
Phone
717-663-4700
PRRC contact
Gloria Zuclich(public in EUDAMED)

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Keystone Industries, the earliest on 2023-04-10 and the most recent on 2023-11-20. By recorded status: 3 ongoing. The reasons filed fall into these groups: labeling or instructions for use and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 3
  • 2024 0
  • 2025 0
  • 2026 0

  • 2023

    • 20 Nov 2023 Z-0630-2024 Class II Ongoing 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). Distribution: Worldwide distribution - US Nationwide and the country of China. Submission number: K203000
    • 21 Jul 2023 Z-2579-2023 Class II Ongoing A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526). Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Bangladesh, Germany, UK. Submission number: K933505
    • 10 Apr 2023 Z-2580-2023 Class II Ongoing 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 Distribution: US Nationwide distribution in the states of IL, PA, FL NV, TX.

From the company website

Read 18 Oct 2026

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

Frequently asked questions

How many devices does Keystone Industries have in the registry?

The registry currently lists 941 devices for Keystone Industries. Devices recorded under merged duplicate company entries are counted once.

Which registries list Keystone Industries's devices?

Among its 50 most recently registered devices, Keystone Industries has devices listed in EUDAMED (50 devices).

What risk classes do Keystone Industries's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Keystone Industries's devices are Class I and Class IIa. Each device page shows its own class and authorisation.

Are there FDA recall records for Keystone Industries?

FDA recall records list 3 recalls initiated by Keystone Industries, the most recent initiated on 20 Nov 2023. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Keystone Industries in the registry?

The most recently registered devices listed for Keystone Industries include Tray Aways, KeyTray, Pro-Form EVA Plus and Blue Tray Material.

Generated automatically from registry data and not verified by a human reviewer.