REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR— 510(k) K070327

Name: FDA 510(k) clearance K070327
Creator: U.S. Food and Drug Administration
Published: 2007-05-25

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K070327 for REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR, Substantially Equivalent on 2007-05-25. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2007-02-05
Decision date: 2007-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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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.