ROOT CANAL FILES & REAMERS— 510(k) K770367

Name: FDA 510(k) clearance K770367
Creator: U.S. Food and Drug Administration
Published: 1977-03-01

Substantially Equivalent

Cemco Tool Co., Inc.

FDA 510(k) clearance K770367 for ROOT CANAL FILES & REAMERS, Substantially Equivalent on 1977-03-01. Applicant: Cemco Tool Co., Inc.. Device class: 1.

Clearance details

Applicant: Cemco Tool Co., Inc.
Product code: Code EKP
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1977-02-22
Decision date: 1977-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKP

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K823686 — REAMER TYPE K ENDODONTIC1982-12-28
K822620 — ROOT CANAL REAMERS, TYPE K1982-09-28
K800291 — ENDEX REAMERS PULP CANAL, ENDODONTIC1980-02-19
K770331 — DIALYSIS, JET SYSTEM1977-04-20
K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL1977-04-05

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