ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE— 510(k) K935625

Name: FDA 510(k) clearance K935625
Creator: U.S. Food and Drug Administration
Published: 1994-08-10

Substantially Equivalent

Wallace A. Erickson & Co.

FDA 510(k) clearance K935625 for ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE, Substantially Equivalent on 1994-08-10. Applicant: Wallace A. Erickson & Co.. Device class: 2.

Clearance details

Applicant: Wallace A. Erickson & Co.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1993-11-22
Decision date: 1994-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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
K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive2025-01-03
K242537 — BracePaste Fluoride Sealant2024-08-27
K234043 — 3M Transbond Orthodontic Adhesive2023-12-22

More clearances from Wallace A. Erickson & Co.

view all

K984503 — ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-0001999-02-26
K963922 — ALPHA-DENT ROOT CANAL SEALER & FILLER1996-12-06
K960667 — CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE1996-07-02
K960365 — ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)1996-03-28
K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT1996-03-15

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