FDA.reportPublic FDA data

Pure PMMA Disc

Primary DI
04806532674858
Brand
Pure PMMA Disc
Company
QUEST DENTAL MATERIAL CORPORATION
Model
Shade: MLC1, Thickness: 25mm
Catalog number
485
Device description
Pure PMMA Discs are polymenthyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
Published
2021-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172281000PuRE PMMA DiscQuest Dental USA Corp.2017-10-19EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04806532674858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04806532674858048065326748584806532674858

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room temperature, avoid direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-870-3895h-mori@quest-pure.com

Regulatory Flags#

DUNS number
721541530
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04806532673929Pure PMMA DiscShade: MLBL1, Thickness: 14mm3922021-06-30
04806532673936Pure PMMA DiscShade: MLBL2, Thickness: 14mm3932021-06-30
04806532673943Pure PMMA DiscShade: MLBL3, Thickness: 14mm3942021-06-30
04806532673950Pure PMMA DiscShade: MLBL4, Thickness: 14mm3952021-06-30
04806532673967Pure PMMA DiscShade: MLA1, Thickness: 14mm3962021-06-30
04806532673974Pure PMMA DiscShade: MLA2, Thickness: 14mm3972021-06-30
04806532673981Pure PMMA DiscShade: MLA3, Thickness: 14mm3982021-06-30
04806532673998Pure PMMA DiscShade: MLA3.5, Thickness: 14mm3992021-06-30
04806532674001Pure PMMA DiscShade: MLA4, Thickness: 14mm4002021-06-30
04806532674018Pure PMMA DiscShade: MLB1, Thickness: 14mm4012021-06-30
04806532674025Pure PMMA DiscShade: MLB2, Thickness: 14mm4022021-06-30
04806532674032Pure PMMA DiscShade: MLB3, Thickness: 14mm4032021-06-30
04806532674049Pure PMMA DiscShade: MLB4, Thickness: 14mm4042021-06-30
04806532674056Pure PMMA DiscShade: MLC1, Thickness: 14mm4052021-06-30
04806532674063Pure PMMA DiscShade: MLC2, Thickness: 14mm4062021-06-30
04806532674070Pure PMMA DiscShade: MLC3, Thickness: 14mm4072021-06-30
04806532674087Pure PMMA DiscShade: MLC4, Thickness: 14mm4082021-06-30
04806532674094Pure PMMA DiscShade: MLD2, Thickness: 14mm4092021-06-30
04806532674100Pure PMMA DiscShade: MLD3, Thickness: 14mm4102021-06-30
04806532674117Pure PMMA DiscShade: MLD4, Thickness: 14mm4112021-06-30

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