COLTENE DRS DENTAL RESTORATIVE SYSTEM— 510(k) K811363

Name: FDA 510(k) clearance K811363
Creator: U.S. Food and Drug Administration
Published: 1981-06-16

Substantially Equivalent

Coltene, Inc.

FDA 510(k) clearance K811363 for COLTENE DRS DENTAL RESTORATIVE SYSTEM, Substantially Equivalent on 1981-06-16. Applicant: Coltene, Inc.. Device class: 2.

Clearance details

Applicant: Coltene, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1981-05-14
Decision date: 1981-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K261246 — SRGC-062026-06-18

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K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM1987-10-27
K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM1987-02-27
K870047 — COLTENE RAPID1987-01-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.