510(k) Report

FDA applicant

Mycone Dental Supply Co. Inc. (Dba Keystone Industries)

Gibbstown, NJ1 decision2021–20211 recall

FDA records 1 decision for Mycone Dental Supply Co. Inc. (Dba Keystone Industries) (Gibbstown, NJ) in 2021: 1 510(k) clearance. All are in product code MQC (Mouthguard, Prescription). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Mycone Dental Supply Co. Inc. (Dba Keystone Industries)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2021high 1 (2023) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Mycone Dental Supply Co. Inc. (Dba Keystone Industries) by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Mycone Dental Supply Co. Inc. (Dba…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQCMouthguard, Prescription1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 20215cite it

What has FDA decided for it lately?

  • K203000KeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) · 20211 recall

The one decision as Mycone Dental Supply Co. Inc. (Dba Keystone Industries) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K203000KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental…Nov 20, 2023Class II

Other applicant names beginning “Mycone”

FDA records each applicant name separately; these may or may not be the same firm.

Mycone Dental Supply Co., Inc. 3Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind 1Mycone Dental Supply Co., T/A Keystone Industries 1Mycone Dental Supply Company, Inc. (Aka Keystone… 1