510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Keystone Industries

Cherry Hill, NJ, US

Keystone Industries appears in FDA device records in Cherry Hill, NJ. FDA records list 3 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
3
Registered establishments
3

FDA records under these names

1 name

FDA records resolved to Keystone Industries carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Keystone Industries - Gibbstownregistration

510(k) clearance history

FDA records hold 3 510(k) clearances for Keystone Industries between 2019 and 2025. The busiest year on record is 2019, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Keystone Industries, by decision year
YearClearances
20191
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K250489FP3DEBISubstantially Equivalent
K241089KeyPrint KeyDenture BaseEBISubstantially Equivalent
K183598KeyPrint KeySplint SoftMQCSubstantially Equivalent

Registered establishments

FDA registered establishments for Keystone Industries, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
22806291000121639Keystone Industries616 Hollywood Ave, CHERRY HILL, NJ 08002 US2026
25233202523320Keystone Industries52 West King St, Myerstown, PA 17067 US2026and 42 more, listed in full below
30100027223010002722Keystone Industries - Gibbstown480 S Democrat Rd, Gibbstown, NJ 08027 US2026and 7 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0630-2024KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011Keyprint 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).Class IIOpen, Classified
Z-2579-2023Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect against penetration of amalgam into the dentina Item No. 0921526A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).Class IIOpen, Classified
Z-2580-2023Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718The 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 materialsClass IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain