FDA.reportPublic FDA data

Diapex Plus

Primary DI
08806383564694
Brand
Diapex Plus
Company
DiaDent Group International
Model
Type B
Catalog number
A1001-502
Device description
Diapex Plus is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material.
Published
2019-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KIFResin, Root Canal Filling

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383564694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383564694088063835646948806383564694

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). It 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 Temperature2 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687789453
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383540995DIAFILA3 Refill PackageA2009-20032026-10-07
08806383541008DIAFILA3.5 Refill PackageA2009-20042026-10-07
08806383541015DIAFILA4 Refill PackageA2009-20052026-10-07
08806383541022DIAFILB1 Refill PackageA2009-20062026-10-07
08806383541039DIAFILB2 Refill PackageA2009-20072026-10-07
08806383541046DIAFILB3 Refill PackageA2009-20082026-10-07
08806383541053DIAFILC2 Refill PackageA2009-20092026-10-07
08806383541060DIAFILC3 Refill PackageA2009-20102026-10-07
08806383541091DIAFILCL Refill PackageA2009-20132026-10-07
08806383541107DIAFILB4 Refill PackageA2009-20142026-10-07
08806383541114DIAFILC1 Refill PackageA2009-20152026-10-07
08806383541121DIAFILC4 Refill PackageA2009-20162026-10-07
08806383541138DIAFILD1 Refill PackageA2009-20172026-10-07
08806383541145DIAFILD2 Refill PackageA2009-20182026-10-07
08806383541152DIAFILD3 Refill PackageA2009-20192026-10-07
08806383541169DIAFILD4 Refill PackageA2009-20202026-10-07
08806383541176DIAFILCapsule Type A1A2009-40012026-10-07
08806383541183DIAFILCapsule Type A2A2009-40022026-10-07
08806383541190DIAFILCapsule Type A3A2009-40032026-10-07
08806383541206DIAFILCapsule Type A3.5A2009-40042026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809264299005Sure-PasteSURE DENT CORPORATIONKIF2026-09-28
08809264299876Sure-Seal RootSURE DENT CORPORATIONKIF2026-09-28
08809518346677CanalPro CalciSealMEDICLUS CO.,LTDKIF2026-09-22
00766054002963BIOSEALESSENTIAL DENTAL SYSTEMS, INC.KIF2026-09-21
D01060620110N1AH Plus Endodontic SealerDentsply De Trey GmbHKIF2026-08-26
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
06976329180256Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180263Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180270Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180287Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180294Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180300Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180317Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31