FDA.report

IvoBase

Primary DI
DIVO628883AN1
Brand
IvoBase
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
628883AN
Catalog number
628883AN
Device description
IvoBase Hybrid Polymer, Monomer, Funnels, Wax parts, Ventilation filter, Separating Fluid, Spatula
Published
2018-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
DIVO628883AN1PrimaryHIBCC0

GMDN Terms

TermDefinition
Denture base resin kitA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448015938
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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