FDA.report

Dentorium

Primary DI
05056079000477
Brand
Dentorium
Company
WRIGHT HEALTH GROUP LIMITED
Model
Anterior 1H lower 65
Catalog number
D1HL65
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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056079000477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056079000477050560790004775056079000477

GMDN Terms

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

Contacts

PhoneEmail
+1(800)847-4209mail@dentorium.com

Regulatory Flags

DUNS number
214045304
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00817169029304Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELM2026-03-11
05056079069658Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070036Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070043Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070050Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070067Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070074Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070081Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070098Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070449Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070456Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070463Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070470Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070487Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070494Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070500Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070517Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070524Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070531Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070548Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070555Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070562Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070579Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070586Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070593Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070609Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070616Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070623Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070630Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18
05056079070647Dentoluxx VWRIGHT HEALTH GROUP LIMITEDELM2026-02-18