FDA.reportPublic FDA data

ORTHOSOURCE

Primary DI
D9115574660
Brand
ORTHOSOURCE
Company
ORTHOSOURCE
Model
557-466
Device description
Green Etch 60 ml syringe
Published
2019-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861245000ORTHOSOURCE ETCH SYSTEMSOrtho Source1986-04-11EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D911557466601PackageHIBCC1In Commercial Distribution
D9115574660PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
151289394
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D911557418C0ORTHOSOURCE557-418-C2019-11-13
D9115574220ORTHOSOURCE557-4222019-11-12
D9115574240ORTHOSOURCE557-4242019-11-12
D9115574680ORTHOSOURCE557-4682019-11-12
D911557617C0ORTHOSOURCE557-617-C2019-11-13
D911557618C0ORTHOSOURCE557-618-C2019-11-13
D9115670400ORTHOSOURCE567-0402019-11-12
D9115670410ORTHOSOURCE567-0412019-11-12
D9115574120ORTHOSOURCE557-4122019-12-17
D9115574150ORTHOSOURCE557-4152019-11-12
D9115574180ORTHOSOURCE557-4182019-11-12
D9115574190ORTHOSOURCE557-4192019-11-12
D9115575150ORTHOSOURCE557-5152019-11-12
D9115575190ORTHOSOURCE557-5192019-11-12
D9115576150ORTHOSOURCE557-6152019-11-12
D9115576170ORTHOSOURCE557-6172019-11-12
D9115576180ORTHOSOURCE557-6182019-11-12
D9115576190ORTHOSOURCE557-6192019-11-12
D9115574670ORTHOSOURCE557-4672019-11-05
D911628112W0ORTHOSOURCE628-112W2022-12-20

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08806387860075Jet Flow Bulk A3Meta Biomed Co., Ltd.EBC2024-11-16
08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
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