FDA.reportPublic FDA data

N.A.

Primary DI
G123AGA121LO0
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
AGA121LO
Published
2020-05-22
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K914476000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914476000VITAPAN ACRYLIC DENTURE TEETHVident1992-03-02ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G123AGA121LO0PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
316267202
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049368016328N.A.38240382402021-02-23
04049368145219N.A.38210382102021-02-23
04049368145226N.A.38215382152021-02-23
04049368172505N.A.40006400062021-02-23
04049368172512N.A.40008400082021-02-23
04049368014201N.A.33960339602021-02-23
04049368015420N.A.38634386342021-02-23
04049368114154N.A.31306313062021-02-23
04049368127895N.A.32935329352021-02-23
04049368127925N.A.32936329362021-02-23
04049368127932N.A.32937329372021-02-23
04049368127994N.A.32944329442021-02-23
04049368133810N.A.33831338312021-02-23
04049368140818N.A.36282362822021-02-23
04049368141181N.A.36312363122021-02-23
04049368141631N.A.36364363642021-02-23
04049368141648N.A.36366363662021-02-23
04049368141655N.A.36368363682021-02-23
04049368169680N.A.32947329472021-02-23
04049368171423N.A.38606386062021-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01L3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10