RELAX-O-GUARD— 510(k) K925064

Name: FDA 510(k) clearance K925064
Creator: U.S. Food and Drug Administration
Published: 1993-09-13

Substantially Equivalent for Some Indications

Aquatemp Service Co., Inc.

FDA 510(k) clearance K925064 for RELAX-O-GUARD, Substantially Equivalent for Some Indications on 1993-09-13. Applicant: Aquatemp Service Co., Inc.. Device class: 1.

Clearance details

Applicant: Aquatemp Service Co., Inc.
Product code: Code KMY
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1992-10-06
Decision date: 1993-09-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMY

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K931615 — NITE-GUIDE1995-04-14
K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC1995-02-13
K924351 — GLENROE ELASTIBITE STIMULATOR1994-01-06
K924975 — THE ORTHOTRAINER1993-07-08
K924974 — THE TMJ APPLIANCE1993-06-23

Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

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.