510(k) Report

FDA applicant

TMJ Concepts

Ventura1 decision1999–19994 recalls

FDA records 1 decision for TMJ Concepts (Ventura) in 1999: 1 original PMA approval. All are in product code LZD (Joint, Temporomandibular, Implant). 4 recalls are linked to its devices, 1 Class I.

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 TMJ Concepts’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for TMJ Concepts since 2007.

Recalls per year

1in 2026

2018: 12022: 12025: 1, 1 Class I2026 (partial year): 1
2007high 1 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — TMJ Concepts 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?

  • LZDJoint, Temporomandibular, Implant1decision

What has FDA decided for it lately?

  • P980052TMJ Concepts Patient-Fitted TMJ Reconstruction ProsthesisTMJ Concepts · 19991 Class I recall

The one decision as TMJ Concepts →

What has been recalled?

4 recalls linked to its devices; the latest:

  • P980052TMJ Bilateral Implants, REF: CHG020Feb 11, 2026Class II
  • P980052TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx OnlyOct 13, 2025Class I
  • P980052Patient-Fitted Temporomandibular (TMJ) Reconstruction ProsthesisDec 6, 2022Class II
  • P980052Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ…Mar 12, 2018Class II