FDA.reportPublic FDA data

BRILLIANT Crios

Primary DI
J00660022901
Brand
BRILLIANT Crios
Company
Coltène/Whaledent AG
Model
60022901
Catalog number
60022901
Device description
BRILLIANT Crios Disc - A3 LT H14BRILLIANT Crios is a high-performance composite bloc/disc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM grinding process. BRILLIANT Crios is available in a variety of shades and sizes.Composition: Dental glass, cross-linked methacrylates, amorphous silica
Published
2019-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K181500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181500000BRILLIANT CriosColtene/Whaledent AG2018-08-15EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J00660022901PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin dental inlayA custom-made dental restoration made of resin-based material that is bonded within the center of a tooth (intracoronal) typically to serve as a well-fitting, long-lasting alternative to dental fillings for tooth decay or similar damage. It is fabricated indirectly in a dental lab, sometimes by computer-aided design/computer-aided manufacturing (CAD/CAM) techniques, before being fitted and bonded to the damaged tooth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not expose to direct sunlight or other heat sources
Special Storage Condition, Specify00Storage 4-23 °C / 39-73 °F

Contacts#

Phone, Email table
PhoneEmail
+41717575300info.ch@coltene.com

Regulatory Flags#

DUNS number
480017482
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181476947BRILLIANT EverGlowUniv. Comp B-EA1 2025-07-08
07640181476954BRILLIANT EverGlowUniv. Comp B-EA22025-07-08
07640181476961BRILLIANT EverGlowUniv. Comp B-EA32025-07-08
07640181476985BRILLIANT EverGlowUniv. Comp B-EB12025-07-08
J00672800Etchant Gel728072802016-08-15
J00673730Etchant Gel737373732016-08-15
J00673740Etchant Gel737473742016-08-15
J00656300SwissTEC Etchant563056302016-08-15
J0065630L0SwissTEC Etchant5630 L5630 L2016-08-15
J00656310SwissTEC Etchant563156312016-08-15
J00644450PSI444544452016-08-15
J00644400PSI444044402016-08-15
07640181476879BRILLIANT Bulk Fill Flow600368242025-04-29
07640181476886BRILLIANT Bulk Fill Flow600332802025-04-29
J0006600332800BRILLIANT Bulk Fill Flow600332802024-09-22
J0006600368240BRILLIANT Bulk Fill Flow600368242024-09-22
J006600117570One Coat Bond60011757600117572016-08-15
J006600195380ONE COAT 7 UNIVERSAL60019538600195382016-08-15
J006600195390ONE COAT 7 UNIVERSAL60019539600195392016-08-15
J006600195400ONE COAT 7 UNIVERSAL60019540600195402016-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBF2026-08-25
08809518345663One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
08809518345670One-Temp FlowMEDICLUS CO.,LTDEBF2026-08-12
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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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
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