FDA.reportPublic FDA data

ELEDENT

Primary DI
08435288468747
Brand
ELEDENT
Company
UNION DENTAL SA
Model
POSTERIOR TEETH D3/32MI
Catalog number
M9D332MI
Device description
ELEDENT posterior Teeth Shade D3, Mould 32M low.
Published
2024-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070591000REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETHUnion Dental S.A./Unidesa.Odi2007-05-11ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435288468747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435288468747084352884687478435288468747

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

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
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA40NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25