FDA.report

Primeprint Temp A3

Primary DI
EDET028151
Brand
Primeprint Temp A3
Company
DETAX GmbH & Co. KG
Model
02815
Published
2021-12-22
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
EDET028151PrimaryHIBCC0

GMDN Terms

TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317099257
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
EDET021651detax Impression lacquer 1000 ml021652022-10-26
EDET025891detax Impression lacquer 30 ml025892022-10-26
EDET041641medicalprint shell blue opaque 1000g041642022-10-26
EDET041651medicalprint shell red opaque 1000g041652022-10-26
EDET042301detax softwear 2.0 clear 40 shore 8x 50 ml042302022-10-26
EDET042381detax softwear 2.0 blue 60 shore 2 x 50 ml042382022-10-26
EDET042461luxaprint flex UV 500 g 042462022-10-26
EDET027231aquaplus putty blue 2 x 250 ml027232022-10-25
EDET027241aquaplus putty red 2 x 250 ml027242022-10-25
EDET029411protect mold neon pink 2 x 100ml029412022-10-25
EDET029461protect mold neon green 2 x 100ml029462022-10-25
EDET029471protect mold neon green 2 x 100ml029472022-10-25
EDET029481protect mold neon orange 2 x 100ml029482022-10-25
EDET029491super coat 100ml029492022-10-25
EDET029501super coat 300ml029502022-10-25
EDET029911earflex 40 sh rainbow 8 x 50 ml029912022-10-25
EDET030121express coat 100ml030122022-10-25
EDET030141dip coat 100ml030142022-10-25
EDET030151dip coat 250ml030152022-10-25
EDET031921earflex 40 sh clear 8 x 50 ml031922022-10-25

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