510(k) Report

FDA applicant

Premier Dental Products Co.

Mchenry, IL44 decisions1977–20262 recalls

FDA records 44 decisions for Premier Dental Products Co. (Mchenry, IL) from 1977 to 2026: 44 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 1 days from receipt to decision, against 63 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Premier Dental Products Company”.

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 Premier Dental Products Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2009: 12013: 22014: 12022: 12025: 12026 (partial year): 1
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Premier Dental Products Co. 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?

  • KLEAgent, Tooth Bonding, Resin4decisions
  • EBFMaterial, Tooth Shade, Resin4decisions
  • EMACement, Dental4decisions
  • EJRAgent, Polishing, Abrasive, Oral Cavity2decisions
  • MVLCord, Retraction2decisions
  • EKHCarver, Dental Amalgam, Operative1decision

Also: EMS (1), EHY (1), EKN (1), ETF (1), EBI (1), GDG (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 1 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 63 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 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.

  • K033309Premier Implant Cement, Model 3001450Premier Dental Products Co. · 20043cite it
  • K132526Knit-Pak+Premier Dental Products Co. · 20132cite it
  • K062166Enamel ProPremier Dental Products Co. · 20062cite it
  • K083695TraxodentPremier Dental Products Co. · 20092cite it
  • K891536Enamel Microabrasion CompoundPremier Dental Products Co. · 19891cites it
  • K771451ScutabondPremier Dental Products Co. · 19771cites it

What has FDA decided for it lately?

  • K260682Bond-PR™ Universal AdhesivePremier Dental Products Company · 2026
  • K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company · 2025
  • K223632Premier's MultiMatch Universal Chameleon Restorative CompositePremier Dental Products Company · 2022
  • K141839Premier EtchPremier Dental Products Co. · 2014
  • K132526Knit-Pak+Premier Dental Products Co. · 2013
  • K131212Premier Ceramic PrimerPremier Dental Products Co. · 2013
  • K083695TraxodentPremier Dental Products Co. · 2009
  • K062166Enamel ProPremier Dental Products Co. · 2006

All 41 as Premier Dental Products Co. →All 3 as Premier Dental Products Company →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K970992Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical…Apr 29, 2004
  • K970992Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical IntrstrumentApr 29, 2004