FDA.reportPublic FDA data

Crowntec

Primary DI
D93180651
Brand
Crowntec
Company
Saremco Dental AG
Model
B1
Catalog number
8065
Device description
saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for production of 3D-printed permanent crowns, inlays, onlays, veneers, temporary crowns & bridges, and artificial teeth (i.e., complete or partial dentures).
Published
2022-03-15
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
EBGCrown And Bridge, Temporary, Resin
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213343000Saremco Print CROWNTECSaremco Dental AG2022-01-21EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D93180651PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

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
D93170501els extra low shrinkage composite syringeC470502026-04-28
D93171011els extra low shrinkage composite syringeA371012026-04-28
D93180131els unibond/80132026-04-28
D93180511CrowntecA380512022-03-15
D93180521Crowntec A280522022-03-15
D93180631Crowntec A180632022-03-15
D93180661Crowntec sw80662022-03-15

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Primary DI, Brand, Company table
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