FDA.report

MARK3

Primary DI
D7964105
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
4105
Device description
Temporary 10:1 Crown & Bridge B1 75gm. Cartridge & 10 Tips - MARK3
Published
2021-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7964105PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
096191093
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
D7969003MARK390032025-03-06
D7969001MARK390012025-02-28
00850014374532MARK3855-016XC855-016XC2024-07-24
00850014374549MARK3848-018XC848-018XC2024-07-24
00850014374556MARK3652S-018XC652S-018XC2024-07-24
00850014374563MARK3655S-018XC655S-018XC2024-07-24
00850014374570MARK3855-018C855-018C2024-07-24
00850014374587MARK3652S-017XC652S-017XC2024-07-24
D79616501MARK3165016502024-07-22
D79616521MARK3165216522024-07-22
D79616541MARK3165416542024-07-22
D79614260MARK3142614262023-11-15
D7961426X0MARK31426X1426X2023-11-15
D79614300MARK3143014302023-11-15
D79614320MARK3143214322023-11-15
D79614330MARK3143314332023-11-15
D79619112MARK3191119112023-11-09
D79619122MARK3191219122023-11-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
08800055726953C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D35A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD18A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25
E235DD18A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25
E235DD18A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25