FDA.reportPublic FDA data

Occlude Aerosol Articulation Marking 75g Green

Primary DI
00310866000220
Brand
Occlude Aerosol Articulation Marking 75g Green
Company
PASCAL COMPANY, INC.
Model
05305
Catalog number
05305
Device description
Aerosol articulation marking spray, 75 grams. green
Published
2019-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFHPaper, Articulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310866000220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866000220003108660002203108660002200310866000220

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paste/solutionA substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004268051pascal@pascaldental.com

Regulatory Flags#

DUNS number
009260217
Device count
1
Lot or batch
true
Expiration date on label
true

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00310866000275KnitTrax Plain Retraction Cord 00007569075692019-01-29
00310866000282KnitTrax Plain Retraction Cord 0007570075702019-01-29
00310866000299KnitTrax Plain Retraction Cord 007575075752019-01-29
00310866000305KnitTrax Plain Retraction Cord 107580075802019-01-29
00310866000312KnitTrax Plain Retraction Cord 207585075852019-01-29
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Primary DI, Brand, Company table
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