FDA.reportPublic FDA data

Visalys BioCeramic Block

Primary DI
E217150801
Brand
Visalys BioCeramic Block
Company
Kettenbach GmbH & Co. KG
Model
15080
Catalog number
15080
Device description
Visalys BioCeramic Block Implant Translucent
Published
2026-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K241131000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241131000edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCKEdelweiss Dentistry Products GmbH2024-10-18EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E217150801PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316803246
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E217135901Visalys CemCore Try In Paste13590135902019-11-25
E217135911Visalys CemCore Try In Paste13591135912019-11-25
E217135921Visalys CemCore Try In Paste13592135922019-11-25
E217135931Visalys CemCore Try In Paste13593135932019-11-25
E217135941Visalys CemCore Try In Paste13594135942019-11-25
E217149401ProphyProtect149402026-06-08
E217119291Futar11929119292026-04-02
E217150601Visalys Bulk Fill150602026-03-05
E217150611Visalys Bulk Fill150612026-03-05
E217150621Visalys Bulk Fill150622026-03-05
E217150681Visalys Bulk150682026-03-05
E217150761Visalys BioCeramic Block15076150762026-01-09
E217150751Visalys BioCeramic Block150752026-01-19
E217150851Visalys BioCeramic Block15085150852026-01-19
E217150701Visalys BioCeramic Block15070150702026-01-09
E217150711Visalys BioCeramic Block15071150712026-01-09
E217150721Visalys BioCeramic Block15072150722026-01-09
E217150731Visalys BioCeramic Block15073150732026-01-09
E217150741Visalys BioCeramic Block15074150742026-01-09
E217150811Visalys BioCeramic Block15081150812026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062153846NeoFilKerr CorporationEBF2026-11-04
00766054003045BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003052BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003069BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003076BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003083BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003090BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003106BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003113BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003120BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003137BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
EDMG2228071Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228081Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228091Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228121Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228131Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228141Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228151Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228161Ecosite Elements Highlight Refill IncisalDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228181Ecosite Elements Highlight Refill WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228191Ecosite Elements Highlight Refill BrownDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228201Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228211Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228221Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228231Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228251Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228261Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228271Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30