FDA.reportPublic FDA data

SonicFill 3

Primary DI
00841396185281
Brand
SonicFill 3
Company
Kerr Corporation
Model
36713
Device description
Sonic-Activated, Single-Fill Composite; Unidose Refill; A3
Published
2018-07-18
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
EBCSealant, Pit And Fissure, And Conditioner
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143209000SonicFill 2Sybron Dental Specialties2015-02-05EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841396185281PrimaryGS10
00841396194986Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841396185281008413961852818413961852810841396185281
00841396194986008413961949868413961949860841396194986

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8005377123xxx@xxx.xxx

Regulatory Flags#

DUNS number
199354556
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062145582ZenFlex CM818-36022026-02-19
00195062145599ZenFlex CM818-36032026-02-19
00195062145605ZenFlex CM818-36042026-02-19
00195062145612ZenFlex CM818-36052026-02-19
00195062145629ZenFlex CM818-36062026-02-19
00195062145636ZenFlex CM818-36072026-02-19
00195062145643ZenFlex CM818-36082026-02-19
00195062145650ZenFlex CM818-36092026-02-19
00195062145667ZenFlex CM818-36102026-02-19
00195062145674ZenFlex CM818-36112026-02-19
00195062145681ZenFlex CM818-36122026-02-19
00195062145698ZenFlex CM818-36132026-02-19
00195062145704ZenFlex CM818-36142026-02-19
00195062145711ZenFlex CM818-36152026-02-19
00195062145728ZenFlex CM818-36162026-02-19
00195062145735ZenFlex CM818-36172026-02-19
00195062145742ZenFlex CM818-36182026-02-19
00195062145247ZenFlex CM818-36022026-02-19
00195062145254ZenFlex CM818-36032026-02-19
00195062145261ZenFlex CM818-36042026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08809518340668Once-Fil FlowMEDICLUS CO.,LTDEBF2026-05-28
08809254453875Dual CoreVERICOM CO., LTD.EBF2026-05-27
08809254453943Dual CoreVERICOM CO., LTD.EBF2026-05-27
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
07615208006247SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006254SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006261SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006278SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
EMICEHR6T1Ena HRI ®MICERIUM SPAEBF2021-12-09
EMICEHFUD61Ena HFO ®MICERIUM SPAEBF2021-12-01
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ESDG2320491Capo Natural Incisal medium, 4 gSchütz Dental GmbHEBC2016-11-08
ESDG2321121Capo Slow Flow capsules A 1, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321121Capo Slow Flow capsules A 1, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321131Capo Slow Flow capsules A 2, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321131Capo Slow Flow capsules A 2, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321141Capo Slow Flow capsules A 3, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321141Capo Slow Flow capsules A 3, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321151Capo Slow Flow capsules clear, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321151Capo Slow Flow capsules clear, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321221Capo Hybrid A 3, 0.3 gSchütz Dental GmbHEBF2016-11-08
ESDG2321221Capo Hybrid A 3, 0.3 gSchütz Dental GmbHEBC2016-11-08