Premium Teeth Resin— 510(k) K240538

Substantially Equivalent

Formlabs Ohio, Inc.

FDA 510(k) clearance K240538 for Premium Teeth Resin, Substantially Equivalent on 2024-07-19. Applicant: Formlabs Ohio, Inc.. Device class: 2.

Clearance details

Applicant: Formlabs Ohio, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2024-02-26
Decision date: 2024-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Millbury, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from Formlabs Ohio, Inc.

K262300 — Denture Base Resin V22026-07-08
K232087 — Dental LT Comfort Resin2024-02-16
K222061 — Dental LT Clear V2 Resin2022-11-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.