FDA.reportPublic FDA data

IDODENTINE

Primary DI
08435288443584
Brand
IDODENTINE
Company
UNION DENTAL SA
Model
DISC DARK PINK V3 (#200) 98,5/25mm
Catalog number
4225/#200 (V3)
Device description
IDODENTINE DISC DARK PINK V3 98,5/25mm
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150432000IDODENTINE DISC, IDODENTINE BLOCKUnion Dental S.A.2015-08-14EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435288443584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435288443584084352884435848435288443584

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
462114760
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435288492353ANAXDENT PMMAU Monolayer BLANK A1 98,5/16mm189300162025-12-15
08435288492360ANAXDENT PMMAU Monolayer BLANK A2 98,5/16mm189500162025-12-15
08435288492377ANAXDENT PMMAU Monolayer BLANK A3 98,5/16mm189100162025-12-15
08435288492513ANAXDENT PMMAU Monolayer BLANK BL1 98,5/16mm189600162025-12-15
08435288492537ANAXDENT PMMAU Monolayer BLANK BL3 98,5/16mm189700162025-12-15
08435288492544ANAXDENT PMMAU Monolayer BLANK BL4 98,5/16mm189400162025-12-15
08435288443591IDODENTINEDISC DARK PINK V3 (#200) 98,5/30mm4230/#200 (V3)2025-07-30
08435288443614IDODENTINEDISC DARK PINK V2 (#1L) 98,5/25mm4225/#1L (V2)2025-07-30
08435288443645IDODENTINEDISC DARK PINK V1 (#1) 98,5/25mm4225/#1 (V1)2025-07-30
08435288443669IDODENTINEDISC DARK PINK V2 (#1L) 98,5/30mm4230/#1L (V2)2025-07-30
08435288443690IDODENTINEDISC DARK PINK V1 (#1) 98,5/30mm4230/#1 (V1)2025-07-30
0843528848103610TEMPDISC A3,5 5 LAYERS 95/20mmRGZ-A3.5-202020-01-07
0843528848083110TEMPDISC A3,5 5 LAYERS 98,5/20mmRGW-A3.5-202019-12-27
08435288493183ANAXDENT PMMAU 10-LAYER BLANK BL2 98,5/30mm181312302025-07-22
08435288493190ANAXDENT PMMAU 10-LAYER BLANK BL3 98,5/30mm181313302025-07-22
08435288493206ANAXDENT PMMAU 10-LAYER BLANK BL4 98,5/30mm181414302025-07-22
08435288493244ANAXDENT PMMAZ 10-LAYER BLANK A3,5 95/30mm181425302025-07-22
08435288493664ANAXDENT PMMAZ Monolayer BLANK A3 95/20mm188900202025-07-22
08435288493817ANAXDENT PMMAZ Monolayer BLANK BL2 95/20mm188600202025-07-22
08435288494067ANAXDENT PMMAZ Monolayer BLANK A3 95/25mm188910252025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942201747619FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
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06942201747787FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-11-03
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