FDA applicant

Blue Dent Dental

Pirassununga, BR1 decision2018–20180 recalls

FDA records 1 decision for Blue Dent Dental (Pirassununga, BR) in 2018: 1 510(k) clearance. All are in product code EBG (Crown And Bridge, Temporary, Resin). 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 Blue Dent Dental’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Blue Dent Dental by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Blue Dent Dental’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

Other applicant names beginning “Blue”

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

Blue Belt Technologies, Inc. 22 Blue Sky Bio, LLC 21 Blue Ridge Media Co. 11 Blue Ortho 9 Blue Sky Medical Group Incorporated 4 Blue Planet Industries, Inc. 3 Blue Torch Medical Technologies 2 Blue Sail Medical Co.,Ltd 2 Blue X Imaging Srl 2 Blue Spark Technologies, Inc. 2 Blue & Red Corp. 1 Blue Focus 1

Blue Dent Dental

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Blue”