FDA.reportPublic FDA data

FLNT Temp

Primary DI
06942201747602
Brand
FLNT Temp
Company
Liaoning Upcera Co.,Ltd.
Model
TD-S-C1 D98-20
Published
2026-11-03
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
06942201747602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942201747602069422017476026942201747602

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
06942201746810FLNT TempTD-S-BL3 D98-122026-11-03
06942201746827FLNT TempTD-S-A3.5 D98-122026-11-03
06942201746834FLNT TempTD-S-B4 D98-122026-11-03
06942201746841FLNT TempTD-S-D2 D98-122026-11-03
06942201747008FLNT TempTD-S-BL2 D98-142026-11-03
06942201747022FLNT TempTD-S-B3 D98-142026-11-03
06942201747039FLNT TempTD-S-C4 D98-142026-11-03
06942201747107FLNT TempTD-M-BL3 D98-142026-11-03
06942201747121FLNT TempTD-M-B4 D98-142026-11-03
06942201747138FLNT TempTD-M-D2 D98-142026-11-03
06942201747213FLNT TempTD-S-B2 D98-162026-11-03
06942201747220FLNT TempTD-S-C3 D98-162026-11-03
06942201747299FLNT TempTD-M-BL2 D98-162026-11-03
06942201747312FLNT TempTD-M-B3 D98-162026-11-03
06942201747411FLNT TempTD-S-C2 D98-182026-11-03
06942201747428FLNT TempTD-S-D4 D98-182026-11-03
06942201747480FLNT TempTD-M-BL1 D98-182026-11-03
06942201747503FLNT TempTD-M-B2 D98-182026-11-03
06942201747510FLNT TempTD-M-C3 D98-182026-11-03
06942201747619FLNT TempTD-S-D3 D98-202026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201746810FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201746827FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201746834FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201746841FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747008FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747022FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747039FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747107FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747121FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747138FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747213FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747220FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747299FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747312FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747411FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747428FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747480FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747503FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747510FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747619FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747718FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747770FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747787FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747794FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747800FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747893FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747909FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747961FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747985FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
06942201747992FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03