FDA.reportPublic FDA data

ANAXDENT PMMA

Primary DI
08435288492360
Brand
ANAXDENT PMMA
Company
UNION DENTAL SA
Model
U Monolayer BLANK A2 98,5/16mm
Catalog number
18950016
Device description
ANAXDENT PMMA DISC U Monolayer BLANK COLOR A2 98,5/16mm
Published
2025-12-15
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

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
08435288492360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435288492360084352884923608435288492360

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended 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
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
08435288494067ANAXDENT PMMAZ Monolayer BLANK A3 95/25mm188910252025-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201775735FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
06942201776206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-15
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBG2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBG2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBG2026-10-09
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226731Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226748Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226755Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226762Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226779Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226786Solventum™ Protemp™Solventum Germany GmbHEBG2026-10-08
00197998226809Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226816Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
00197998226823Solventum™ Paradigm™Solventum Germany GmbHEBG2026-10-08
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