FDA applicant

Dimensional Bioceramics, LLC

Santa Cruz, CA5 decisions2017–20210 recalls

FDA records 5 decisions for Dimensional Bioceramics, LLC (Santa Cruz, CA) from 2017 to 2021: 5 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and GXP (Methyl Methacrylate For Cranioplasty). Since 2016 its 510(k)s took a median of 52 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 0 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, orthopedic panel, where it files most

How often FDA has decided Dimensional Bioceramics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2017high 2 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Dimensional Bioceramics, LLC by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Dimensional Bioceramics, LLC’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 “Dimensional”

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

Dimensional Medicine, Inc. 4 Dimensional Dosing Systems, Inc. 1

Dimensional Bioceramics, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Dimensional”