FDA.report

FLNT Temp

Primary DI
06942201747398
Brand
FLNT Temp
Company
Liaoning Upcera Co.,Ltd.
Model
TD-S-A1 D98-18
Published
2026-05-26
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
true

Related Records

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions

SubmissionSupplement
K253380000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253380000“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.2026-03-02EBG

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06942201747398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06942201747398069422017473986942201747398

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.

Regulatory Flags

DUNS number
548214192
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
true
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
06942201747329FLNT TempTD-M-C4 D98-162026-05-26
06942201747404FLNT TempTD-S-B1 D98-182026-05-26
06942201747497FLNT TempTD-M-A2 D98-182026-05-26
06942201747589FLNT TempTD-S-BL4 D98-202026-05-26
06942201747596FLNT TempTD-S-A4 D98-202026-05-26
06942201747688FLNT TempTD-M-A1 D98-202026-05-26
06942201747695FLNT TempTD-M-B1 D98-202026-05-26
06942201747701FLNT TempTD-M-C2 D98-202026-05-26
06942201747886FLNT TempTD-M-A4 D98-222026-05-26
06942201747978FLNT TempTD-S-A3 D98-252026-05-26
06942201746728FLNT TempTD-M-A1 D98-102026-05-22
06942201747015FLNT TempTD-S-A3 D98-142026-05-22
06942201747114FLNT TempTD-M-A3.5 D98-142026-05-22
06942201747190FLNT TempTD-S-BL1 D98-162026-05-22
06942201747206FLNT TempTD-S-A2 D98-162026-05-22
06942201747305FLNT TempTD-M-A3 D98-162026-05-22
06941382286740Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-182026-03-20
06941382286757Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-202026-03-20
06941382286764Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-222026-03-20
06941382286771Gradual Dental Zirconia BlankGT(F)P1-M-BL2 D95-252026-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06942201747329FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747404FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747497FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747589FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747596FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747688FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747695FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747701FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747886FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747978FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201746728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747114FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747190FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
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