FDA.reportPublic FDA data

FLNT Temp

Primary DI
06942201789442
Brand
FLNT Temp
Company
Liaoning Upcera Co.,Ltd.
Model
TD-S-A1 D98-25
Published
2026-10-17
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
06942201789442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942201789442069422017894426942201789442

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
06942480719550FLNT BaseRD-Pink D98-222026-10-19
06942480719567FLNT BaseRD-V-Pink D98-222026-10-19
06942480720396FLNT BaseRD-Pink D98-182026-10-19
06942480720402FLNT BaseRD-V-Pink D98-182026-10-19
06942480720617FLNT BaseRD-Pink D98-302026-10-19
06942480720624FLNT BaseRD-V-Pink D98-302026-10-19
06942480721454FLNT BaseRD-Pink D98-252026-10-19
06942480721461FLNT BaseRD-V-Pink D98-252026-10-19
06942480722284FLNT BaseRD-Pink D98-202026-10-19
06942480722291FLNT BaseRD-V-Pink D98-202026-10-19
06942480722505FLNT BaseRD-Pink D98-352026-10-19
06942480722512FLNT BaseRD-V-Pink D98-352026-10-19
06942480723335FLNT BaseRD-Pink D98-282026-10-19
06942480723342FLNT BaseRD-V-Pink D98-282026-10-19
06942201776305FLNT TempTD-M-A3 D98-352026-10-17
06942201788100FLNT TempTD-S-A3 D98-102026-10-17
06942201788292FLNT TempTD-S-A2 D98-122026-10-17
06942201788391FLNT TempTD-M-A3 D98-122026-10-17
06942201788483FLNT TempTD-S-A1 D98-142026-10-17
06942201788582FLNT TempTD-M-A2 D98-142026-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788100FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788292FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788391FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788483FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788582FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788773FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788780FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788797FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788971FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789060FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789152FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789169FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789183FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789251FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789350FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789459FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789541FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789732FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201790028FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707816FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707915FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707939FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708004FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708011FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708103FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708295FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708301FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708318FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17