FDA applicant

Oral Osteodistraction, L.P.

Appollo Beach, FL3 decisions2003–20050 recalls

FDA records 3 decisions for Oral Osteodistraction, L.P. (Appollo Beach, FL) from 2003 to 2005: 3 510(k) clearances. All are in product code MQN (External Mandibular Fixator And/Or Distractor). Its devices cite 5 predicates, 1 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 Oral Osteodistraction, L.P.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oral Osteodistraction, L.P. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oral Osteodistraction, L.P. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Oral”

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

Oral-B Laboratories 8 Oral Iceberg S.L. 1 Oral Image, Inc. 1 Oral Health Technologies, LLC 1 Oral Biotech 1

Oral Osteodistraction, L.P.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Oral”