FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions

SubmissionSupplement
K852741000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K852741000DURA CONDITIONERReliance Dental Mfg. Co.1985-09-23EBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9471805PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
708-597-6694service@reliancedental.net

Regulatory Flags

DUNS number
005139159
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
D9471601N1Duraliner II – Nylon Fiber1601-N2022-08-03
D9472243B1DURALAY - BLUE2243-B2022-08-03
D9472243C1DURALAY - CLEAR2243-C2022-08-03
D9472244DURALAY - Red22442022-08-03
D9472244B1DURALAY - BLUE2244-B2022-08-03
D9472244C1DURALAY - CLEAR2244-C2022-08-03
D9472249A1DURALAY - Red2249A2022-08-03
D9472249AB1DURALAY - BLUE2249A-B2022-08-03
D9472249AC1DURALAY - CLEAR2249A-C2022-08-03
D9472249DC1DURALAY - CLEAR2249D-C2022-08-03

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