DSG RELAXER SPLINT— 510(k) K022627

Name: FDA 510(k) clearance K022627
Creator: U.S. Food and Drug Administration
Published: 2003-03-18

Substantially Equivalent

Sentage Corporation D/B/A/ Dental Services Group

FDA 510(k) clearance K022627 for DSG RELAXER SPLINT, Substantially Equivalent on 2003-03-18. Applicant: Sentage Corporation D/B/A/ Dental Services Group. Device class: Unclassified.

Clearance details

Applicant: Sentage Corporation D/B/A/ Dental Services Group
Product code: Code MQC
Device class: Unclassified
Advisory panel: Unknown
Date received: 2002-08-07
Decision date: 2003-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQC

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K250743 — Remvia NightGuard2025-12-05
K251252 — NOBILCAM IMPAK Disc2025-08-01
K241729 — Hard Splint & Thermo-Adaptive Splint2025-03-18
K243516 — Remi Custom Night Guard2025-02-10

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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