Sybron Endo Sealapex Root Canal Sealer

$59.21

Manufactured by: SybronEndo, model Sealapex:

Made in: South Korea:

Intended for use: across dental laboratory, dentistry, dermatology, and endodontic applications:

Supplied: new, unused, and unopened in its original packaging, with expiration date printed on the product:

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Brand: SybronEndo
Model: Sealapex
Country of Origin: South Korea
Condition: New, unused, unopened, in original packaging
Expiration Date: Printed on the product
Intended Use/Discipline: Dental laboratory, dentistry, dermatology, endodontics

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Sybron Endo Sealapex Root Canal Sealer is a non-eugenol, radiopaque root canal sealer formulated with calcium hydroxide and polymeric resin. It is supplied as a two-part base and catalyst paste system and is designed for use in root canal obturation. Sealapex can be used with endodontic obturation techniques, including the single cone technique when used with a properly fitted master cone. It is intended for professional dental use and should be used according to the manufacturer's instructions for use supplied with the product.

Sealapex received FDA 510(k) clearance as a calcium hydroxide polymeric resin root canal filling material, tested to meet the ISO 6876:2012 standard for root canal sealing materials, which sets requirements including maximum film thickness. Manufacturer filings also note biocompatibility testing to ISO 10993. No CE marking or other regional certification could be independently confirmed for this specific product, so none is claimed here.

FDA 510(k)

ISO 6876:2012

ISO 10993

12g base tube
18g catalyst tube
mixing pads
directions for use (Manual)

Dental

Dental laboratory Dentistry Dermatology Endodontics

Store away from direct sunlight

in the original container, kept tightly closed when not in use; carefully reseal opened containers and keep them upright to prevent leakage

Use with adequate general or local exhaust ventilation

to keep exposure levels below occupational limits; no additional respiratory protection is typically needed under normal use with adequate ventilation

If skin or eye irritation occurs

get medical attention if it persists; do not induce vomiting if ingested

Some formulations/components

carry a California Prop 65 cancer warning per manufacturer safety data sheets

Follow standard clinical infection control and disposal protocols

empty containers can retain product residue and should be handled per SDS guidance