FDA.reportPublic FDA data

Dura Conditioner Bulk Package - White

Primary DI
D9471805
Brand
Dura Conditioner Bulk Package - White
Company
Reliance Dental Manufacturing Co Inc
Model
1805
Device description
Short term denture relining material/PACKAGE 4 LBS. POWDER / 4 - 16 OZ. LIQUID (113 GR POWDER / 472 ML LIQUID EACH)
Published
2022-08-23
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852741000DURA CONDITIONERReliance Dental Mfg. Co.1985-09-23EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9471805PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
708-597-6694service@reliancedental.net

Regulatory Flags#

DUNS number
005139159
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9471401Durabase - Pink14012023-01-13
D9471506Durabase Soft - Pink15062023-01-13
D9471601Duraliner II - Pink16012023-01-13
D9472150DURALAY II QUICK CURE LAB PATTER RESIN - PINK21502023-01-13
D9472243DURALAY COMBINATION PKG. - Red22432023-01-13
D9472249D1DURALAY - RED2249D2023-01-13
D9472249DB1DURALAY - BLUE2249D-B2023-01-13
D9472503DURALAY – Temporary Crown & Bridge Kit25032023-01-13
D9472706DURASEAL27062023-01-13
D9472709DURASEAL27092023-01-13
D9471701Dura Rely-A-Soft Complete Package - Pink17012022-08-23
D9471701C1Dura Rely-A-Soft Complete Package - Clear1701-C2022-08-23
D9471706Dura Rely-A-Soft Economy Package - Pink17062022-08-23
D9471706C1Dura Rely-A-Soft Economy Package - Clear1706-C2022-08-23
D9471801Dura Conditioner Complete Package - White18012022-08-23
D9471801P1Dura Conditioner Complete Package - Pink1801-P2022-08-23
D9471805P1Dura Conditioner Bulk Package - Pink1805-P2022-08-23
D9471401C1Durabase - Clear1401-C2022-08-03
D9471506C1Durabase Soft - Clear1506-C2022-08-03
D9471601C1Duraliner II - Clear1601-C2022-08-03

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