DRY RITE DRYING AGENT

Primary DI
D701SDRY2
Brand
DRY RITE DRYING AGENT
Company
PULPDENT CORPORATION
Model
DRY
Device description
KIT: 4 x 1.2 mL syringes + 8 pre-bent dropper tips
Published
2018-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K896654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K896654000DRYING AGENTPulpdent Corp.1990-02-14EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D701SDRY2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.2Milliliter

Regulatory Flags#

DUNS number
001006089
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D701DEN2DENTIN CONDITIONING GELDEN2016-07-21
D701EA2ETCH-ALL™ EA2016-09-01
D701EA52ETCH-ALL™ Dental Etching Gel EA52016-07-28
D701ER2ETCH ROYALE™ DENTAL ETCHING GELER2016-08-11
D701ER242ETCH ROYALE™ DENTAL ETCHING GEL ER242016-08-11
D701ER502ETCH ROYALE™ DENTAL ETCHING GELER502016-08-11
D701ER50R2Etch RoyaleER50R2016-09-01
D701ER62ETCH ROYALE™ DENTAL ETCHING GEL ER62016-08-11
D701ET122ETCH-RITE™ DENTAL ETCHING GEL ET122016-07-28
D701ET12G2ETCH-RITE™ DENTAL ETCHING GEL ET12G2016-07-28
D701ET182ETCHANTET182016-09-01
D701ET242ETCH-RITE™ DENTAL ETCHING GEL ET242016-08-11
D701ET502ETCH-RITE™ DENTAL ETCHING GEL ET502016-08-11
D701ET50R2ETCH-RITE™ DENTAL ETCHING GELET50R2016-08-11
D701ET62ETCH-RITE™ DENTAL ETCHING GELET62016-07-28
D701ETCH2ETCH-RITE™ DENTAL ETCHING GELETCH2016-07-28
D701ETTWIN2ETCH-RITE™ DENTAL ETCHING GEL ETTWIN2016-07-28
D701SER2ETCH ROYALE SAMPLESER2018-08-10
D701SETCH2ETCH RITE SAMPLESETCH2018-08-10
D701ET1442ETCH-RITE™ DENTAL ETCHING GEL ET1442016-08-11

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