510(k) Report

FDA applicant

Primus Consulting

Bradenton, FL1 decision2007–20070 recalls

FDA records 1 decision for Primus Consulting (Bradenton, FL) in 2007: 1 510(k) clearance. All are in product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Primus Consulting’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 — Primus Consulting 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?

  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision

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.

  • K061252Pre-Cemented Orthodontic Bracket SystemPrimus Consulting · 20072cite it

What has FDA decided for it lately?

  • K061252Pre-Cemented Orthodontic Bracket SystemPrimus Consulting · 2007

The one decision as Primus Consulting →

Other applicant names beginning “Primus”

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

Primus Corp. 14Primus Sterilizer Company, LLC 6Primus Gloves Private, Ltd. 4Primus Gloves Pvt Limited 3Primus Corporation Dba Trinity Biotech 1