FDA 510(k) ISO 6876:2012 ISO 10993
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Dental Consumables

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:::
Top Highlights
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.

≤50 µm Max film thickness per ISO 6876
2-part Base and catalyst system
12g / 18g Typical base/catalyst tube sizes

Key features

1 Non-eugenol calcium hydroxide formula

Promotes periapical healing and hard tissue formation, per manufacturer product information

2 Two-part base/catalyst system

Mixed in equal portions before placement

3 Compatible with the single cone technique

Works with a properly fitted master cone for an effective apical and lateral seal

4 Multi-discipline application

Intended for use across dental laboratory, dentistry, dermatology, and endodontic settings, per item specifics

5 Supplied new and sealed

New, unused, unopened, in original packaging, with the expiration date printed on 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
Sybron Endo Sealapex Root Canal Sealer
  • 12g base tube
  • 18g catalyst tube
  • mixing pads
  • directions for use (Manual)

Setting

Dental laboratories Dental clinics Dermatology practices Endodontic practices ##Used By Dentists Endodontic professionals
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

Questions

Frequently Asked Questions

Root canal sealing in endodontic procedures; the listing category also references dental laboratory, dentistry, and dermatology use
South Korea
New, unused, unopened, in its original packaging
Printed on the product itself
Non-eugenol, calcium hydroxide-based, per manufacturer product information
Yes, provided a properly fitted master cone is used for an effective seal, per manufacturer information
No certifications were stated in the original listing. Manufacturer/FDA filing research indicates Sealapex holds FDA 510(k) clearance and meets ISO 6876 testing standards

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