1 STEP— 510(k) K792003

Substantially Equivalent

Betta Dental, Inc.

FDA 510(k) clearance K792003 for 1 STEP, Substantially Equivalent on 1979-11-27. Applicant: Betta Dental, Inc.. Device class: 2.

Clearance details

Applicant: Betta Dental, Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 1979-10-03
Decision date: 1979-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYH

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

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