510(k) Report

FDA applicant

Parkell, Inc.

Farmingdale, NY61 decisions1976–20250 recalls

FDA records 61 decisions for Parkell, Inc. (Farmingdale, NY) from 1976 to 2025: 61 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EMA (Cement, Dental). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 143 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Parkell”.

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 Parkell, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 22010: 12012: 12014: 12015: 22017: 12018: 12019: 22022: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Parkell, 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?

  • KLEAgent, Tooth Bonding, Resin16decisions
  • EMACement, Dental8decisions
  • EBFMaterial, Tooth Shade, Resin6decisions
  • ELCScaler, Ultrasonic4decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing3decisions
  • EBGCrown And Bridge, Temporary, Resin3decisions

Also: EAT (3), ELW (3), LQY (2), EBD (2), KOJ (1), EJK (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 143 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 18 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 6 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.

  • K960464C & B Metabond (Modification)Parkell, Inc. · 19967cite it
  • K950239Sensimatic 500SEParkell, Inc. · 19952cite it
  • K942017V-PrimerParkell, Inc. · 19941cites it
  • K950256TURBO 25/30Parkell, Inc. · 19951cites it
  • K243254Parkell Pit and Fissure SealantParkell, Inc. · 20251cites it
  • K010475D/C Core MaterialParkell, Inc. · 20011cites it

What has FDA decided for it lately?

  • K243254Parkell Pit and Fissure SealantParkell, Inc. · 2025
  • K210259Parkell Self-Adhesive CementParkell, Inc. · 2022
  • K191103Parkell Desensitizer GelParkell, Inc. · 2019
  • K190930SmarTemp X1Parkell, Inc. · 2019
  • K182296HyperFil-LVParkell, Inc. · 2018
  • K172176Parkell Universal AdhesiveParkell, Inc. · 2017
  • K151518Brush&Bond PlusParkell, Inc. · 2015
  • K142848Eazy PrimerParkell, Inc. · 2015

All 53 as Parkell, Inc. →All 8 as Parkell →