A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD)— 510(k) K897195

Name: FDA 510(k) clearance K897195
Creator: U.S. Food and Drug Administration
Published: 1990-05-31

Substantially Equivalent

A Company, Inc.

FDA 510(k) clearance K897195 for A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD), Substantially Equivalent on 1990-05-31. Applicant: A Company, Inc.. Device class: 1.

Clearance details

Applicant: A Company, Inc.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1989-12-29
Decision date: 1990-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K970649 — HERO 6421997-05-16
K962031 — QUANTEC SERIES 2000 ENDODONTIC FILES1996-06-04

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K852596 — A-COMPANY ELASTIC LIGATURE RINGS1985-07-31
K852597 — A-COMPANY ELASTIC ROTATION WEDGES1985-07-31
K852598 — A-COMPANY SEPARATING ELASTICS1985-07-31
K852599 — A-COMPANY ELASTOMERIC TUBING1985-07-31
K852600 — A-COMPANY ELASTOMERIC CHAIN DISPENSER1985-07-31

Adverse events under product code EKS

product code EKS

Malfunction: 1,949
Total: 1,949

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.