510(k) Report

FDA applicant

Rapid Injection Systems Corp.

Sound Beach, NY2 decisions1981–20070 recalls

FDA records 2 decisions for Rapid Injection Systems Corp. (Sound Beach, NY) from 1981 to 2007: 2 510(k) clearances. All are in product code EBI (Resin, Denture, Relining, Repairing, Rebasing). No recall is 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 Rapid Injection Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rapid Injection Systems Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions

What has FDA decided for it lately?

  • K072479Flexite Supreme, Flexite Plus, Flexite M.P., Northern and Flexite Pro-GuardRapid Injection Systems Corp. · 2007
  • K810869Silicone Elastomer KitRapid Injection Systems Corp. · 1981

All 2 as Rapid Injection Systems Corp. →

Other applicant names beginning “Rapid”

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

Rapid Medical, Ltd. 12Rapid City Regional Hospital, Inc. 10Rapid Biomedical GmbH 7Rapid Diagnostic Laboratories, Inc. 6Rapid Diagnostics, Inc. 4Rapid Pathogen Screening, Inc. 3Rapid Aid Corp. 3Rapid Reboot Recovery Products, LLC 2Rapid Mfg. Co. 1Rapid-Aid Ltd./Ltee 1Rapid Response Solutions, LLC 1Rapid Nexus Nanotech Wound Solutions, Inc. 1