meddevicedb.com FDA Device Reference

FIRST FILL R.C.S.

K011748 Class II Traditional
Decision Date
2001-08-03
Sponsor / Applicant
Jeneric/Pentron, Inc.

Technical Specification

510(k) Submission ID K011748
Product Code KIF
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.3820
Decision Date 2001-08-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

FIRST FILL R.C.S. received FDA 510(k) clearance under submission number K011748, sponsored by Jeneric/Pentron, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2001-08-03.

Classification & Regulation

This clearance is catalogued under FDA product code KIF and 21 CFR 872.3820, within the Dental review panel as a Class II device.