ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE— 510(k) K973884

Substantially Equivalent

Frantz Design, Inc.

FDA 510(k) clearance K973884 for ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE, Substantially Equivalent on 1998-01-09. Applicant: Frantz Design, Inc..

Clearance details

Applicant: Frantz Design, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1997-10-14
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Webster, TX, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.