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FDA Product Code

FDA Product Code EKP — Clearance Directory

Device Class
Class I
Assigned Panel
Dental
21 CFR Citation
872.4565

510(k) Clearances — 6 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K823686 REAMER TYPE K ENDODONTIC United Dental Mfg., Inc. 1982-12-28 Traditional PDF ↗
K822620 ROOT CANAL REAMERS, TYPE K Union Broach, Div. Moyco Industries, Inc. 1982-09-28 Traditional PDF ↗
K800291 ENDEX REAMERS PULP CANAL, ENDODONTIC Ipco Corp. 1980-02-19 Traditional PDF ↗
K770331 DIALYSIS, JET SYSTEM Janneck Ent. of Texas 1977-04-20 Traditional PDF ↗
K770598 ENDODONTIC INSTRUMENTS, R&R CUTWELL Ransom and Randolph 1977-04-05 Traditional PDF ↗
K770367 ROOT CANAL FILES & REAMERS Cemco Tool Co., Inc. 1977-03-01 Traditional PDF ↗

Product code EKP · Class I · Dental. Data: openFDA.