510(k) Report

FDA applicant

Rodo Medical, Inc.

San Jose, CA3 decisions2016–20200 recalls

FDA records 3 decisions for Rodo Medical, Inc. (San Jose, CA) from 2016 to 2020: 3 510(k) clearances. All are in product code NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 200 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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 Rodo Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2016: 12018: 12020: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Rodo Medical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rodo Medical, 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?

  • NHAAbutment, Implant, Dental, Endosseous3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 200 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K160786RODO Abutment SystemRodo Medical, Inc. · 20162cite it

What has FDA decided for it lately?

  • K193274Rodo Abutment SystemRodo Medical, Inc. · 2020
  • K180609Rodo SmilekeyRodo Medical, Inc. · 2018
  • K160786RODO Abutment SystemRodo Medical, Inc. · 2016

All 3 as Rodo Medical, Inc. →