FDA.report

Etch Rite

Primary DI
D701ET32
Brand
Etch Rite
Company
PULPDENT CORPORATION
Model
ET-3
Catalog number
ET-3
Device description
Etch Rite phosphoric acid etchant; 3 x 3mL syringes + 40 25gauge bent needle tips.
Published
2021-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D701ET32PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001006089
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D701T20G191Applicator TipsT20G192024-12-03
D701SVBFUS2ACTIVA™ BioACTIVE Bulk FlowS-VBFUS2024-12-02
D701SVKBFUS2ACTIVA™ Kids BioACTIVE Bulk FlowS-VKBFUS2024-12-02
D701VBF1US2ACTIVA™ BioACTIVE Bulk FlowVBF1US2024-12-02
D701VKBF1OW2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1OW2024-12-02
D710VKBF1US2ACTIVA™ Kids BioACTIVE Bulk FlowVKBF1US2024-12-02
D701SUNO2DENTASTIC UNO SAMPLESUNO2018-08-10
D701SVPFA32Activa PrestoS-VPFA32023-06-22
D701SVPFA352Activa PrestoS-VPFA352023-06-22
D701SVPFA42Activa PrestoS-VPFA42023-06-22
D701SVPFA62Activa PrestoS-VPFA62023-06-22
D701SVPFB12Activa PrestoS-VPFB12023-06-22
D701TTP502Tuff Temp Plus Provisional Veneer, Crown, and Bridge ResinTTP502018-12-14
D701TTP50A12TUFF-TEMP PLUSTTP50A12019-11-22
D701TTP50A1X2TUFF-TEMP PLUSTTP50A1X2019-11-22
D701TTP50A22TUFF-TEMP PLUSTTP50A22019-11-22
D701TTP50A2X2TUFF-TEMP PLUSTTP50A2X2019-11-22
D701TTP50A32TUFF-TEMP PLUSTTP50A32019-11-22

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