510(k) Report

FDA applicant

Formlabs Ohio, Inc.

Millbury, OH4 decisions2022–20260 recalls

FDA records 4 decisions for Formlabs Ohio, Inc. (Millbury, OH) from 2022 to 2026: 4 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and EBG (Crown And Bridge, Temporary, Resin). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Formlabs Ohio, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2022: 12024: 22026 (partial year): 1
2022high 2 (2024) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Formlabs Ohio, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Formlabs Ohio, Inc.’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

Which product codes does it file in?

  • MQCMouthguard, Prescription2decisions
  • EBGCrown And Bridge, Temporary, Resin1decision
  • EBIResin, Denture, Relining, Repairing, Rebasing1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 132 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 20221cites it

What has FDA decided for it lately?

  • K262300Denture Base Resin V2Formlabs Ohio, Inc. · 2026
  • K240538Premium Teeth ResinFormlabs Ohio, Inc. · 2024
  • K232087Dental LT Comfort ResinFormlabs Ohio, Inc. · 2024
  • K222061Dental LT Clear V2 ResinFormlabs Ohio, Inc. · 2022

All 4 as Formlabs Ohio, Inc. →