Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive— 510(k) K250015

Name: FDA 510(k) clearance K250015
Creator: U.S. Food and Drug Administration
Published: 2025-01-03

Substantially Equivalent

Ormco Corporation

FDA 510(k) clearance K250015 for Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive, Substantially Equivalent on 2025-01-03. Applicant: Ormco Corporation. Device class: 2.

Clearance details

Applicant: Ormco Corporation
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2025-01-02
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYH

view all

K261129 — OrthoFit2026-07-02
K261840 — BracePaste Prime Plus2026-06-03
K242537 — BracePaste Fluoride Sealant2024-08-27
K234043 — 3M Transbond Orthodontic Adhesive2023-12-22
K231817 — AlignerFlow LC2023-12-01

More clearances from Ormco Corporation

view all

K250487 — SparkTM Clear Aligner System2025-02-20
K240501 — Spark Clear Aligner System2024-10-11
K203737 — Spark Clear Aligner System2021-03-22
K172845 — Symetri Clear2018-01-31
K171844 — Inspire ICE aka Inspire ICE Clear Brackets2017-07-18

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