510(k) Report

FDA applicant

Biotech One, Inc.

Laguna Niguel, CA2 decisions2004–20060 recalls

FDA records 2 decisions for Biotech One, Inc. (Laguna Niguel, CA) from 2004 to 2006: 2 510(k) clearances. Most are in product codes JEY (Plate, Bone) and MVL (Cord, Retraction). 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 Biotech One, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biotech One, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biotech One, Inc. 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?

  • JEYPlate, Bone1decision
  • MVLCord, Retraction1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K040650Bonamates SeriesBiotech One, Inc. · 20041cites it

What has FDA decided for it lately?

  • K053329Korlex-GR Gingival Retraction PasteBiotech One, Inc. · 2006
  • K040650Bonamates SeriesBiotech One, Inc. · 2004

All 2 as Biotech One, Inc. →

Other applicant names beginning “Biotech”

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

Biotech Dental, Sas 4Biotech Atlantic, Inc. 4Biotech Research Laboratories, Inc. 2Biotech Dental Smilers, Sas 1Biotech Lubricants, Ltd. 1Biotech, Inc. 1Biotech Medical Instruments Corp. 1