FDA.report

Resin Teeth DCL PE

Primary DI
DIVO5649581
Brand
Resin Teeth DCL PE
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
564958
Catalog number
564958
Device description
SR Vivodent DCL 6er UA3 A3,5
Published
2019-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ELMDenture, plastic, teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO5649581PrimaryHIBCC0

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

Regulatory Flags

DUNS number
448015938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

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