FDA.reportPublic FDA data

10TEMP

Primary DI
08435288480909
Brand
10TEMP
Company
UNION DENTAL SA
Model
DISC C2 5 LAYERS 98,5/20mm
Catalog number
RGW-C2-20
Device description
10TEMP RATAVA DISC 5 LAYERS COLOR C2 98,5/20mm
Published
2020-01-07
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
08435288480909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435288480909084352884809098435288480909

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
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
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02