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Sign in to claim this brandKeystone 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
- facebook.com/KeystoneInd
- [email protected]
- Phone
- 717-663-4700
- PRRC Contact
- Gloria Zuclich
- EUDAMED SRN
- US-MF-000020203
- FDA FEI Number
- 2523320
- DUNS Number
- —
Catalogue (909)
Page 19 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KeyDentureTry-In | 4200401 | EUDAMEDFDA UDI | Class I | Active |
| ItsoClear | 1009152 | EUDAMEDFDA UDI | Class I | Active |
| KeyOrtho IBT | 4200008 | EUDAMEDFDA UDI | Class I | Active |
| ItsoClear | 1009151 | EUDAMEDFDA UDI | Class I | Active |
| Diamond D Ultra Impact Denture Acrylic | 1013014 | EUDAMEDFDA UDI | Class IIa | Active |
| ItsoClear | 1009153 | EUDAMEDFDA UDI | Class I | Active |
| Diamond D Ultra Impact Denture Acrylic | 1013015 | EUDAMEDFDA UDI | Class IIa | Active |
| Pro-Form EVA Plus | 7000190 | EUDAMEDFDA UDI | Class I | Active |
| ItsoClear | 1009150 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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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 |