SEALAPEX 4— 510(k) K010940

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K010940 for SEALAPEX 4, Substantially Equivalent on 2001-06-20. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2001-03-29
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

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More clearances from Sybron Dental Specialties, Inc.

K093341 — CENTURY MODEL 105C2010-04-05
K091091 — SONICFILL 20102009-10-14
K080089 — SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS2008-09-04
K073478 — SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS2008-09-03
K071615 — FIXAFLOSS2007-09-21

Recalls naming K010940

K-number listed on FDA's recall record

Z-2836-2016 — Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.Class II·Terminated·Ormco/Sybronendo·20160831

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010940.

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