FDA.reportPublic FDA data

Tubli-Seal EWT Xpress

Primary DI
00889989074239
Brand
Tubli-Seal EWT Xpress
Company
ORMCO CORPORATION
Model
33641
Device description
Root Canal Sealer-Zinc Oxide Eugenol - Dual Syringe Delivery System (2 - 5mL Syringes)
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIFRESIN, ROOT CANAL FILLING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153067000Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties2016-07-27KIF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989074239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989074239008899890742398899890742390889989074239

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight21.4Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18005377123EndoRotaryCustCare@kerrdental.com

Regulatory Flags#

DUNS number
154614119
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989079494Tevdek II975-00502016-09-08
00889989079500Tevdek II975-00522016-09-08
00889989079517Tevdek II975-00542016-09-08
00889989079524Tevdek II975-00562016-09-08
00889989079531Tevdek II975-00632016-09-12
00889989079548Tevdek II975-00652016-09-12
00889989079555Tevdek II975-00672016-09-12
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989088885Ormco™ EtchFree Bonding740-05002025-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518341511Any-PasteMEDICLUS CO.,LTDKIF2026-06-01
08809518345106One-Fil Putty InjectableMEDICLUS CO.,LTDKIF2026-05-21
06972902583292C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
06972902583308C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
08404535015126Brasseler USAPeter Brasseler Holdings, LLCKIF2026-04-29
08809518346608CanalPro CalciSealMEDICLUS CO.,LTDKIF2026-04-23
08809262954371VioSealSpident Co., Ltd.KIF2026-04-20
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
07290115050523BJM Root Canal SealerB.J.M. LABORATORIES LTDKIF2026-03-20
00195062152771ZenSeal ProKerr CorporationKIF2026-02-10
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCKIF2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.KIF2025-11-27
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06976329180324Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180331Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180348Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180355Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31