FDA.reportPublic FDA data

Dentorium

Primary DI
05056079001221
Brand
Dentorium
Company
WRIGHT HEALTH GROUP LIMITED
Model
Anterior 23 lower 61
Catalog number
D23L61
Device description
Polymer Teeth - Set
Published
2016-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056079001221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056079001221050560790012215056079001221

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)847-4209mail@dentorium.com

Regulatory Flags#

DUNS number
214045304
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056079069658Dentoluxx VAnterior 133 Upper A2DXV133UA22026-02-18
05056079070036Dentoluxx VAnterior 1H Upper A2DXV1HUA22026-02-18
05056079070043Dentoluxx VAnterior 3M Upper A2DXV3MUA22026-02-18
05056079070050Dentoluxx VAnterior 156 Upper A2DXV156UA22026-02-18
05056079070067Dentoluxx VAnterior 274 Upper A2DXV274UA22026-02-18
05056079070074Dentoluxx VAnterior 23 Lower A2DXV23LA22026-02-18
05056079070081Dentoluxx VAnterior 32 Lower A2DXV32LA22026-02-18
05056079070098Dentoluxx VAnterior PE Upper B1DXVPEUB12026-02-18
05056079070449Dentoluxx VPosterior PE Upper A1DXVPEUA12026-02-18
05056079070456Dentoluxx VPosterior PE Upper A3DXVPEUA32026-02-18
05056079070463Dentoluxx VPosterior PE Upper A3.5DXVPEUA3.52026-02-18
05056079070470Dentoluxx VPosterior PE Upper A4DXVPEUA42026-02-18
05056079070487Dentoluxx VPosterior PE Upper B2DXVPEUB22026-02-18
05056079070494Dentoluxx VPosterior PE Upper B3DXVPEUB32026-02-18
05056079070500Dentoluxx VPosterior PE Upper B4DXVPEUB42026-02-18
05056079070517Dentoluxx VPosterior PE Upper C1DXVPEUC12026-02-18
05056079070524Dentoluxx VPosterior PE Upper C2DXVPEUC22026-02-18
05056079070531Dentoluxx VPosterior PE Upper C3DXVPEUC32026-02-18
05056079070548Dentoluxx VPosterior PE Upper C4DXVPEUC42026-02-18
05056079070555Dentoluxx VPosterior PE Upper D2DXVPEUD22026-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
EPOLCL02A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10