FDA.reportPublic FDA data

Maquira

Primary DI
07898561546678
Brand
Maquira
Company
Maquira Industria de Produtos Odontologicos S/A
Model
Fill Canal Kit (Liquid 10 mL + Powder 12 g)
Catalog number
80322400128
Device description
"""Fill Canal is a material for root canal filling that acts by the reaction between its main components: Zinc Oxide (powder) and Eugenol (liquid). Fill Canal presents essential characteristics for an endodontic cement: good tolerance by the tissues, radiopacity and impermeability. Fill Canal has extra fine granulation, allowing an homogeneous and creamy mixture, without clots."""
Published
2024-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898561546678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898561546678078985615466787898561546678

GMDN Terms#

Term, Definition table
TermDefinition
Zinc oxide eugenol dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
679266866
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898570928151PriZma 3D Bio Splint Soft - Colorless (250 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928168PriZma 3D Bio Splint Soft - Colorless (500 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898570928175PriZma 3D Bio Splint Soft - Colorless (1000 g)PRIZMA 3D BIO SPLINT 804837490082025-09-12
07898561546999PriZma 3D Bio Splint - Transparent (500 g)PriZma 3D Bio Splint2025-09-05
07898561547002PriZma 3D Bio Splint - Transparent (250 g)PriZma 3D Bio Splint804837400012025-09-05
07898561547019PriZma 3D Bio Guide - Ambar (1000 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547026PriZma 3D Bio Guide - Ambar (500 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547033PriZma 3D Bio Guide - Ambar (250 g)PriZma 3D Bio Guide804837400032025-09-05
07898561547330PriZma 3D Bio Ortho IBT (1000 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547347PriZma 3D Bio Ortho IBT (500 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547354PriZma 3D Bio Ortho IBT (250 g)PriZma 3D Bio Ortho804837400042025-09-05
07898561547736PriZma 3D Bio Crown - BL (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547743PriZma 3D Bio Crown - BL (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547767PriZma 3D Bio Crown - A1 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547774PriZma 3D Bio Crown - A1 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547798PriZma 3D Bio Crown - A2 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561547804PriZma 3D Bio Crown - A2 (500 g)PriZma 3D Bio Crown804837490052025-09-05
07898561548238PriZma 3D Bio Crown - A3 (250 g)PriZma 3D Bio Crown804837490052025-09-05
07898561549020PriZma 3D Bio Crown Diamond - BL (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05
07898561549037PriZma 3D Bio Crown Diamond A1 (300 g)PriZma 3D Bio Crown Diamond804837490072025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591690DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
08806383591706DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
00817169021421Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMB2026-03-11
D161280140AxioIRM 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
D161280150AxioIRM 75g powder 40ml liquidAxiodent Inc.EMB2024-09-29
D161280160AxioIRM XS 38g powder 14ml liquidAxiodent Inc.EMB2024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
07898561542205MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542212Fill Canal Liquid (10 mL) 7898561542212 Maquira MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542236MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542250MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546685MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
00816526020220MASTER-DENTDENTONICS INCEMB2023-10-31
00816526020237MASTER-DENTDENTONICS INCEMB2023-10-31
05021752001065Alganol Powder 90gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-09-11
15060988910045JJ CAREJack Jack LLCEMB2023-07-15
05021752000723Eugenol B.P. Liquid 150mlASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
05021752000761Zinc Oxide B.P. Powder 150gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
10852253006240Power Temp Cartridge KitJ. MORITA U.S.A., INCEMB2023-06-07
10852253006257Power Temp Mini Syringe KitJ. MORITA U.S.A., INCEMB2023-06-07
D95600ZOERF0Zoer ReinforcedD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9560ZOERQS0Zoer QuickD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9673001510ZinconolPREVEST DENPRO LIMITEDEMB2023-01-03
D967300160ZitempPREVEST DENPRO LIMITEDEMB2023-01-03
D967300150ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D96730015A09ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
H66811475771Keystone IndustriesKeystone IndustriesEMB2022-11-30
H66811475781Keystone IndustriesKeystone IndustriesEMB2022-11-30