510(k) Report

FDA applicant

Williams Dental Co., Inc.

Buffalo, NY2 decisions1989–19894 recalls

FDA records 2 decisions for Williams Dental Co., Inc. (Buffalo, NY) in 1989: 2 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EBF (Material, Tooth Shade, Resin). 4 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 Williams Dental Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Williams Dental Co., Inc. since 2007.

Recalls per year

4in 2017

2017: 4
2007high 4 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Williams Dental 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?

  • KIFResin, Root Canal Filling1decision
  • EBFMaterial, Tooth Shade, Resin1decision

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.

  • K893794Apexit Root Canal SealerWilliams Dental Co., Inc. · 19892cite it

What has FDA decided for it lately?

  • K893794Apexit Root Canal SealerWilliams Dental Co., Inc. · 1989
  • K884588Heliomolar (R) Dental RestorativeWilliams Dental Co., Inc. · 19894 recalls

All 2 as Williams Dental Co., Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K884588Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501Aug 3, 2017Class III
  • K884588Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503Aug 3, 2017Class III
  • K884588Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559Aug 3, 2017Class III
  • K884588Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502Aug 3, 2017Class III

Other applicant names beginning “Williams”

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

Williams Gold Refining Co., Inc. 26Williams Medical Co. 5Williams Sound, LLC 4Williams Manufacturing Co. 4Williams Specialty Products, Inc. 2Williams Healthcare Systems, LLC 2Williams Importing Company, Inc. 1Williams & Connolly 1Williams Airway Intubator 1Williams, the J.B. Co., Inc. 1