COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM— 510(k) K873671

Name: FDA 510(k) clearance K873671
Creator: U.S. Food and Drug Administration
Published: 1987-10-27

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K873671 for COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM, Substantially Equivalent on 1987-10-27. Applicant: Coltene, Inc.. Device class: 1.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EKS
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1987-09-11
Decision date: 1987-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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

More clearances from Coltene, Inc.

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K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL1990-08-28
K882800 — COLTENE PRESIDENT JET REGULAR BODY1988-09-23
K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
K870047 — COLTENE RAPID1987-01-29
K863998 — COLTENE JET-MIXER1986-10-30

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.