510(k) Report

FDA applicant

Robert A James

San Diego, CA2 decisions1994–19940 recalls

FDA records 2 decisions for Robert A James (San Diego, CA) in 1994: 2 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Robert A James’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Robert A James since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Robert A James 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?

  • DZEImplant, Endosseous, Root-Form2decisions

What has FDA decided for it lately?

  • K926100Spiral Lock Dental Implant SystemRobert A James · 1994
  • K925796Spiral Lock Dental Implant SystemRobert A James · 1994

All 2 as Robert A James →

Other applicant names beginning “Robert”

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

Robert Bosch Corp. 21Robert I. Chien & Assoc., Inc. 6Robert R. Moore 5Robert W. Bauer & Assoc., Inc. 3Robert R. Stevens 2Robert Reid, Inc. 2Robert B. Scott Ocularists of Florida, Inc. 2Robert J. Sislian, Inc. 1Robert C. Cameron 1Robert Shaw Controls Co. 1Robert C. Leif, Ph.D. 1Robert Bosch Healthcare Systems, Inc. 1