FDA.report

Gloss

Primary DI
D7796243030
Brand
Gloss
Company
COSMEDENT, INC.
Model
624303
Catalog number
624303
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D7796243030PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental crown/bridge resin, temporaryA 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
113911689
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
D7796722B01Bulkfill6722B02022-03-08
D7796722C31Bulkfill6722C32022-03-08
D7796722D21Bulkfill6722D22022-03-08
D7796722351Bulkfill6722352022-03-01
D7796722A11Bulkfill6722A12022-03-01
D7796722A21Bulkfill6722A22022-03-01
D7796722A31Bulkfill6722A32022-03-01
D7796722B11Bulkfill6722B12022-03-01
D779203101116 Gauge Black Tips2031012021-11-11
D7792031021018 Gauge Pink Tips2031022021-11-11
D7792031031119 Gauge Silver Tips2031032021-11-11
D7792031041222 Gauge Black Tips2031042021-11-11
D77920320212Mixing Tips CosmeCore 8gTips2032022021-11-11
D77920320413MirrorImage 10:1 Tips2032042021-11-11
D77920320515Adhere 1:1 Tips2032052021-11-11
D77920320615Connect 4:1 Tips2032062021-11-11
D77920330211CosmeCore IntraOral Tips2033022021-11-11
D77920340213White Plastic Nozzle Tips2034022021-11-11
D77920350315CosmeCore 50g Tip Package2035032021-11-11
D77970351T1Impressiv 5:1 Putty Cartridge Tips70531T2021-11-11

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
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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
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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