FIRST FILL R.C.S.— 510(k) K011748

Substantially Equivalent

Jeneric/Pentron, Inc.

FDA 510(k) clearance K011748 for FIRST FILL R.C.S., Substantially Equivalent on 2001-08-03. Applicant: Jeneric/Pentron, Inc.. Device class: 2.

Clearance details

Applicant: Jeneric/Pentron, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2001-06-06
Decision date: 2001-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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More clearances from Jeneric/Pentron, Inc.

K020499 — BOND-3 ADHESIVE2002-04-22
K013543 — BOND-1 C & B2002-02-22
K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)2002-02-14
K012231 — AVANTE MICRO CRYSTAL SYSTEM2001-08-23
K010957 — QUELL DESENSITIZER2001-06-25

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