FDA.reportPublic FDA data

els extra low shrinkage composite syringe

Primary DI
D93170501
Brand
els extra low shrinkage composite syringe
Company
Saremco Dental AG
Model
C4
Catalog number
7050
Device description
els extra low shrinkage® composite (els composite for short) is a light-curing, highly filled, radiopaque micro hybrid composite with extremely low shrinkage stress for permanent anterior and posterior restorations. els extra low shrinkage® composite is a polymer-based restorative material, Type 1, Class 2, Group 1 and 2 according to DIN EN ISO 4049.
Published
2026-04-28
Public version status
New
Distribution status
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
K240823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240823000els extra low shrinkage® composite & els extra low shrinkage® flowSaremco Dental AG2024-06-27EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D93170501PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
480619001
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D93171011els extra low shrinkage composite syringeA371012026-04-28
D93180131els unibond/80132026-04-28
D93180511CrowntecA380512022-03-15
D93180521Crowntec A280522022-03-15
D93180631Crowntec A180632022-03-15
D93180651Crowntec B180652022-03-15
D93180661Crowntec sw80662022-03-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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