FDA.reportPublic FDA data

FLNT Temp

Primary DI
06942201774950
Brand
FLNT Temp
Company
Liaoning Upcera Co.,Ltd.
Model
TD-M-BL4 D98-16
Published
2026-09-05
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

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253380000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942201774950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942201774950069422017749506942201774950

GMDN Terms#

Term, Definition table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941382296862Gradual Dental Zirconia BlankLT-M-BL2 D98-182026-09-05
06941382296916Gradual Dental Zirconia BlankGT(F)P2-M-A1 D98-302026-09-05
06941382296923Gradual Dental Zirconia BlankGT(F)P2-M-A2 D98-302026-09-05
06941382296930Gradual Dental Zirconia BlankGT(F)P2-M-A3 D98-302026-09-05
06941382296947Gradual Dental Zirconia BlankGT(F)P2-M-A3.5 D98-302026-09-05
06941382296954Gradual Dental Zirconia BlankGT(F)P2-M-B1 D98-302026-09-05
06941382296961Gradual Dental Zirconia BlankGT(F)P2-M-B2 D98-302026-09-05
06942201762285FLNT TempTD-M-A3 D98-302026-09-05
06942201762377FLNT TempTD-S-A1 D98-352026-09-05
06942201762476FLNT TempTD-M-A2 D98-352026-09-05
06942201774288FLNT TempTD-S-A2 D98-102026-09-05
06942201774387FLNT TempTD-M-A3 D98-102026-09-05
06942201774479FLNT TempTD-S-A1 D98-122026-09-05
06942201774578FLNT TempTD-M-A2 D98-122026-09-05
06942201774769FLNT TempTD-M-A1 D98-142026-09-05
06942201774967FLNT TempTD-M-A4 D98-162026-09-05
06942201774981FLNT TempTD-M-D3 D98-162026-09-05
06942201775056FLNT TempTD-S-A3 D98-182026-09-05
06942201775155FLNT TempTD-M-A3.5 D98-182026-09-05
06942201775179FLNT TempTD-M-D2 D98-182026-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28