Dentalis

Primary DI
04560128312608
Brand
Dentalis
Company
NEO DENTAL CHEMICAL PRODUCTS CO.,LTD.
Model
Liquid
Device description
Endodontic sealing material, 10mL Liquid
Published
2016-12-14
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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971642000DENTALIS KEZ ENDODONITC SEALERNeodental Chemical Products Co., Ltd.1997-07-24EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560128312608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560128312608045601283126084560128312608

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include, but are not limited to, silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to direct sunlight.
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
253-946-0814karin@neodental-intl.com

Regulatory Flags#

DUNS number
691229181
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04560128312530VitapexTips Set2016-12-08
04560128312547VitapexRefill2016-12-14
04560128312554VitapexIntro Kit2016-12-14
14560128312629Neo Blue Tips-2021-05-13
04560128312578EVADYNE TEMPORARY CROWN AND BRIDGE RESIN2017-11-07
04560128312561Cavios2018-04-16
04560128312585DentalisSet2016-12-05
04560128312592DentalisPowder2016-12-14

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