FDA.reportPublic FDA data

DIRECTCROWN

Primary DI
D752DP21
Brand
DIRECTCROWN
Company
DIRECT CROWN PRODUCTS
Model
DP2
Device description
2OZ ACRYLIC POWDER SHADE D3
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D752DP21PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Contacts#

Phone, Email table
PhoneEmail
541-431-1187phil@directcrown.com

Regulatory Flags#

DUNS number
120580910
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D752AK3DIRECTCROWNAK2016-09-01
D752AKT3DIRECTCROWNAKT2016-09-01
D752AP3DIRECTCROWNAP2016-09-01
D752AT3DIRECTCROWNAT2016-09-01
D752COMPBO1DIRECTCROWNCOMPBO2016-09-01
D752DC2AK3DIRECTCROWNDC2AK2016-09-01
D752DC2PK3DIRECTCROWNDC2PK2016-09-01
D752DL1DIRECTCROWNDL2016-09-01
D752DP1DIRECTCROWNDP2016-09-01
D752DPA21DIRECTCROWNDPA22016-09-01
D752DPB11DIRECTCROWNDPB12016-09-01
D752DPC11DIRECTCROWNDPC12016-09-01
D752DPC21DIRECTCROWNDPC22016-09-01
D752DPC31DIRECTCROWNDPC32016-09-01
D752NAT12L1DIRECTCROWNNAT12L2016-09-01
D752NAT12M1DIRECTCROWNNAT12M2016-09-01
D752NAT12S1DIRECTCROWNNAT12S2016-09-01
D752NAT13L1DIRECTCROWNNAT13L2016-09-01
D752NAT13M1DIRECTCROWNNAT13M2016-09-01
D752NAT13S1DIRECTCROWNNAT13S2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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