FDA.reportPublic FDA data

S/ETCH

Primary DI
DO3681000401
Brand
S/ETCH
Company
SDI LIMITED
Model
S/ETCH 3X2ML SYR KT
Catalog number
8100040
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K941899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941899000SDI COMPOSTIESSouthern Dental Industries, Inc.1994-07-05EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DO3681000401PrimaryHIBCC0
DO3681000400Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental etching solutionAn acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18002285166info@sdi.com.au

Regulatory Flags#

DUNS number
753221852
Device count
3
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09336472033439Dentsply Sirona Mixer554606855460682026-07-03
29336472004747BENCO ADMIX510230351023032026-02-17
29336472004754BENCO SPHERICAL510236351023632026-02-17
29336472004860BENCO ADMIX512230351223032026-02-17
29336472004877BENCO SPHERICAL512236351223632026-02-17
09336472005450RIVA CEM AUTOMIX880070488007042026-02-16
09336472005474ULTRAMAT 2554604555460452026-02-16
09336472020965RIVA CEM AUTOMIX880070388007032026-02-16
09336472032203RIVA CEM880070088007002026-02-16
09336472038212RIVA STAR880050488005042026-02-16
09336472038366RIVA STAR AQUA880052788005272026-02-16
09336472038403RIVA STAR AQUA880053288005322026-02-16
09336472038441RIVA STAR880053788005372026-02-16
D662070830158PD ADMIX400002540000252026-02-17
D662070830166PD ADMIX400002640000262026-02-17
D662070830273PD ADMIX400000540000052026-02-17
D662070830281PD ADMIX400000640000062026-02-17
D662070900258PD SPHERICAL400006540000652026-02-17
D662070900266PD SPHERICAL400006640000662026-02-17
D662070900373PD SPHERICAL400004540000452026-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062164422OptiGuardKerr CorporationEBF2026-10-29
00195062164439OptiGuardKerr CorporationEBF2026-10-29
00195062160332Build-It FRKerr CorporationEBF2026-10-27
00195062160349Build-It FRKerr CorporationEBF2026-10-27
00195062160356Build-It FRKerr CorporationEBF2026-10-27
00195062160363Build-It FRKerr CorporationEBF2026-10-27
00195062160370Build-It FRKerr CorporationEBF2026-10-27
00195062160387Build-It FRKerr CorporationEBF2026-10-27
00195062160394Build-It FRKerr CorporationEBF2026-10-27
00195062160400Build-It FRKerr CorporationEBF2026-10-27
00195062160417Build-It FRKerr CorporationEBF2026-10-27
00195062160424Build-It FRKerr CorporationEBF2026-10-27
00195062160431Build-It FRKerr CorporationEBF2026-10-27
00195062160448Build-It FRKerr CorporationEBF2026-10-27
00195062160455Build-It FRKerr CorporationEBF2026-10-27
00195062160462Build-It FRKerr CorporationEBF2026-10-27
00195062160479Build-It FRKerr CorporationEBF2026-10-27
00195062160486Build-It FRKerr CorporationEBF2026-10-27
00195062160493Build-It FRKerr CorporationEBF2026-10-27
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25