FDA.report

Maquira

Primary DI
07898561542250
Brand
Maquira
Company
Maquira Industria de Produtos Odontologicos S/A
Model
Provisory Kit base paste (50 g) + accelerator past
Catalog number
80322400123
Device description
Provisory is a cement made of zinc oxide and eugenol for temporary fixation of prosthetic pieces. Provisory forms a thin film, with excellent fluidity and high flow, allowing that the restoration is easily set in place. lt presents adequate resistance to support the masticatory loads. lt also presents low solubility to the oral fluids and it is of easy removal when necessary.
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EMBZinc Oxide Eugenol

Product Code Classifications

CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898561542250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898561542250078985615422507898561542250

GMDN Terms

TermDefinition
Zinc oxide eugenol dental cementA non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
679266866
Device count
1
DM exempt
false
Premarket exempt
true
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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