FDA.reportPublic FDA data

ANAXDENT PMMA

Primary DI
08435288497006
Brand
ANAXDENT PMMA
Company
UNION DENTAL SA
Model
Z 10-LAYER BLANK BL1 95/25mm
Catalog number
18141125
Device description
ANAXDENT PMMA DISC Z 10-LAYER BLANK COLOR BL1 95/25mm
Published
2021-06-11
Public version status
Update
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

Product Code Classifications#

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

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
08435288497006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435288497006084352884970068435288497006

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

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
08435288443584IDODENTINEDISC DARK PINK V3 (#200) 98,5/25mm4225/#200 (V3)2025-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20