510(k) Report

FDA applicant

Sargon Ent., Inc.

Washington, DC3 decisions1994–20100 recalls

FDA records 3 decisions for Sargon Ent., Inc. (Washington, DC) from 1994 to 2010: 3 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Its devices cite 8 predicates, 3 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 Sargon Ent., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sargon Ent., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DZEImplant, Endosseous, Root-Form3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K930071Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 19945cite it
  • K981141Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 19992cite it

What has FDA decided for it lately?

  • K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc. · 2010
  • K981141Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999
  • K930071Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 1994

All 3 as Sargon Ent., Inc. →