FDA.reportPublic FDA data

Estelite Omega

Primary DI
04548190107452
Brand
Estelite Omega
Company
TOKUYAMA DENTAL CORPORATION
Model
10745
Device description
PLT Trans
Published
2016-09-23
Public version status
Update
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
K072746000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072746000E-1 ESTHETIC COMPOSITE SYSTEMTokuyama Dental Corporation2007-12-04EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04548190107452PrimaryGS10
94548190107455Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04548190107452045481901074524548190107452
9454819010745594548190107455

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-378-3548info@tokuyama-us.com

Regulatory Flags#

DUNS number
693552176
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04548190102242OMNICHROMA FLOW102242020-11-14
04548190201723TOKUSO Resin Hardner II201722021-06-25
04548190102228OMNICHROMA BLOCKER FLOW102222020-03-31
04548190101177OMNICHROMA BLOCKER101172018-09-10
04548190101276OMNICHROMA BLOCKER101272018-09-10
04548190101313OMNICHROMA BLOCKER101312018-04-02
04548190101337OMNICHROMA BLOCKER101332018-05-15
04548190101412OMNICHROMA101412018-09-10
04548190101511OMNICHROMA101512018-09-10
04548190131105Estelite Sigma Quick 131102016-09-23
04548190131112Estelite Sigma Quick 131112016-09-23
04548190131129Estelite Sigma Quick 131122016-09-23
04548190131136Estelite Sigma Quick131132016-09-23
04548190131143Estelite Sigma Quick 131142016-09-23
04548190131150Estelite Sigma Quick 131152016-09-23
04548190131167Estelite Sigma Quick131162016-09-23
04548190131174Estelite Sigma Quick 131172016-09-23
04548190131181Estelite Sigma Quick 131182016-09-23
04548190131198Estelite Sigma Quick 131192016-09-23
04548190131204Estelite Sigma Quick 131202016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518340651Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
07615208291964Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291971Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291988Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208291995Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292008Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292015Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292022Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292039Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292046Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292053Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292060Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292077Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292084Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292091Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292107Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292114Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208292121Tetric PrimeIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2023-02-23
07615208006605SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-23
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22