FDA.reportPublic FDA data

STELA

Primary DI
DO3686400011
Brand
STELA
Company
SDI LIMITED
Model
STELA AUTOMIX 1 SYR REFILL
Catalog number
8640001
Published
2024-02-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222581000Stela Automix SystemSdi Limited2022-10-28EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DO3686400011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
753221852
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09336472033439Dentsply Sirona Mixer554606855460682026-07-03
29336472004747BENCO ADMIX510230351023032026-02-17
29336472004754BENCO SPHERICAL510236351023632026-02-17
29336472004860BENCO ADMIX512230351223032026-02-17
29336472004877BENCO SPHERICAL512236351223632026-02-17
09336472005450RIVA CEM AUTOMIX880070488007042026-02-16
09336472005474ULTRAMAT 2554604555460452026-02-16
09336472020965RIVA CEM AUTOMIX880070388007032026-02-16
09336472032203RIVA CEM880070088007002026-02-16
09336472038212RIVA STAR880050488005042026-02-16
09336472038366RIVA STAR AQUA880052788005272026-02-16
09336472038403RIVA STAR AQUA880053288005322026-02-16
09336472038441RIVA STAR880053788005372026-02-16
D662070830158PD ADMIX400002540000252026-02-17
D662070830166PD ADMIX400002640000262026-02-17
D662070830273PD ADMIX400000540000052026-02-17
D662070830281PD ADMIX400000640000062026-02-17
D662070900258PD SPHERICAL400006540000652026-02-17
D662070900266PD SPHERICAL400006640000662026-02-17
D662070900373PD SPHERICAL400004540000452026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208476804Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477719Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477726Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477733Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477740Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477757Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477764Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477771Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477788Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
08806383591676DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591720DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
08806383591911DIAFIL Bulk FLOWDiaDent Group InternationalEBF2026-07-24
00840456224373JMUJMU DENTAL, INCEBF2026-07-22
00840456224380JMUJMU DENTAL, INCEBF2026-07-22
00840456224397JMUJMU DENTAL, INCEBF2026-07-22
00840456224403JMUJMU DENTAL, INCEBF2026-07-22
00840456224410JMUJMU DENTAL, INCEBF2026-07-22
07630243601202ParaCoreDent4You AGEBF2026-07-07
07630243601219ParaCoreDent4You AGEBF2026-07-07
07630243601226ParaCoreDent4You AGEBF2026-07-07