FDA.reportPublic FDA data

MTA Flow

Primary DI
00883205030832
Brand
MTA Flow
Company
ULTRADENT PRODUCTS, INC.
Model
3980-US
Catalog number
3980-US
Device description
MTA Flow
Published
2020-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00883205030832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205030832008832050308328832050308320883205030832

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, Specify00Cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205042835Opalustre5545542026-03-10
00883205044068Enamelast690669062026-02-11
00883205044075Enamelast690769072026-02-11
00883205044082Enamelast691369132026-02-11
00883205044099Enamelast690869082026-02-11
00883205044105Enamelast690969092026-02-11
00883205044112Enamelast691069102026-02-11
00883205044129Enamelast691169112026-02-11
00883205044136Enamelast691269122026-02-11
00883205044983Porcelain Repair110811082026-01-30
00883205044372Valo X6496-DU6496-DU2025-12-04
00883205044389Valo X6497-DU6497-DU2025-12-04
00883205044396Valo X6498-DU6498-DU2025-12-04
00883205044402Valo X6499-DU6499-DU2025-12-04
00883205044419Valo X6519-DU6519-DU2025-12-04
00883205044426Valo X6538-DU6538-DU2025-12-04
00883205044143Enamelast689568952025-11-14
00883205044150Enamelast689668962025-11-14
00883205044167Enamelast689768972025-11-14
00883205044174Enamelast689868982025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
E22116451MTA vptVOCO GmbHKIF2025-07-07
06976329180379Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180386Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180393Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180409Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
06976329180416Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdKIF2025-06-30
D01060620110NA1AH Plus Endodontic Sealer TubesDentsply De Trey GmbHKIF2025-03-31
D01060620115NA1AH Plus Jet Endodontic Sealer Starter KitDentsply De Trey GmbHKIF2025-03-31
D01060620118NA0AH Plus Jet Endodontic Sealer Syringe RefillDentsply De Trey GmbHKIF2025-03-31
07898078659465PURE-Ca-SEAL Angelus Industria de Produtos Odontologicos S AKIF2025-03-20
00883205039187UltraCal XSULTRADENT PRODUCTS, INC.KIF2025-03-11
D690220102SSW ENDOSs White Burs, Inc.KIF2025-02-19
D690220110SSW ENDOSs White Burs, Inc.KIF2025-02-19
D690220122SSW ENDOSs White Burs, Inc.KIF2025-02-19
07898078659939Komet BioRepairAngelus Industria de Produtos Odontologicos S AKIF2024-11-26
10818207024913RE-GEN Bioactive EndoPutty KitVista DentalKIF2024-11-14
00766054002949BIOSEALESSENTIAL DENTAL SYSTEMS, INC.KIF2024-10-31
TQ26126092991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.KIF2024-10-31
10810138823238EndoCeramic Root Repair MaterialEndo Direct LLCKIF2024-10-21
08404535006025BC Sealer Ion+ Angelus Industria de Produtos Odontologicos S AKIF2024-10-15
08404535006414BC Sealer Ion+ Angelus Industria de Produtos Odontologicos S AKIF2024-10-15
08404535006445BC Sealer Ion+Angelus Industria de Produtos Odontologicos S AKIF2024-10-15