Denali Etching Gel

Primary DI
D820DETCH30
Brand
Denali Etching Gel
Company
DENALI CORPORATION
Model
Syringe 3 mL
Catalog number
DETCH3
Device description
Etching Gel, Dental.
Published
2016-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112597000SEITY 37% PHOSPHORIC ACID ETCHANT GELMycone Dental Supply Co., Inc.2011-12-07KLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D820DETCH30PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-781-826-9190denalicorp@denalicorporation.com

Regulatory Flags#

DUNS number
191036107
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D820DETCH120Denali Etching Gel12 mL Etching GelDETCH122016-08-05
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D820ALAYOW3ML0AuraLay Pit and Fissure Sealant3 mL Opaque WhiteALAYOW3ML2016-08-05
D820ALAYXFNT0AuraLay XF Pit and Fissure Sealant1.2 mL Natural TranslucentALAYXFNT2016-08-05
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D820ALAYXFOW0AuraLay XF Pit and Fissure Sealant1.2 mL Opaque WhiteALAYXFOW2016-08-05
D820ALAYXFOW3ML0AuraLay XF Pit and Fissure Sealant3 mL Opaque White2016-08-05
D820APS0Aura Protective Sealer1.2 mL ClearAPS2016-08-05
D820BONNT0Bonita Pit and Fissure Sealant1.2 mL Natural TranslucentBONNT2016-08-05
D820BONOW1Bonita Pit and Fissure Sealant1.2 mL Opaque WhiteBONOW2016-08-05
D820CV0ClearVue Pit & Fissure Sealant and Sealer1.2 mL ClearCV2016-08-05

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