510(k) Report

FDA applicant

Pearl Digital, Inc.

Santa Clara, CA1 decision2025–20250 recalls

FDA records 1 decision for Pearl Digital, Inc. (Santa Clara, CA) in 2025: 1 510(k) clearance. All are in product code NXC (Aligner, Sequential). 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 Pearl Digital, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Pearl Digital, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Pearl Digital, Inc.’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 “Pearl”

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