510(k) Report

FDA applicant

Majestic Drug Co., Inc.

Orange, CT3 decisions1982–20102 recalls

FDA records 3 decisions for Majestic Drug Co., Inc. (Orange, CT) from 1982 to 2010: 3 510(k) clearances. Most are in product codes EBP (Reliner, Denture, Over The Counter) and EMB (Zinc Oxide Eugenol). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Majestic Drug Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2022: 12023: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Majestic Drug Co., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • EBPReliner, Denture, Over The Counter1decision
  • EMBZinc Oxide Eugenol1decision
  • EMACement, Dental1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K101771Reline-IT Model Reline-ITMajestic Drug Co., Inc. · 20101cites it
  • K964773Dentemp One StepMajestic Drug Co., Inc. · 19971cites it

What has FDA decided for it lately?

  • K101771Reline-IT Model Reline-ITMajestic Drug Co., Inc. · 2010
  • K964773Dentemp One StepMajestic Drug Co., Inc. · 19972 recalls
  • K821581Den TempMajestic Drug Co., Inc. · 1982

All 3 as Majestic Drug Co., Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K964773Dentemp One Step .077OZ, Sku 902139Oct 4, 2023Class II
  • K964773Dentemp One Step .077OZ, Sku 902139Jun 23, 2022Class II