FDA.reportPublic FDA data

DIRECTCROWN

Primary DI
D752AK3
Brand
DIRECTCROWN
Company
DIRECT CROWN PRODUCTS
Model
AK
Device description
ADULT POLYCARBONATE POSTERIOR KIT CONTAINING 1OZ ACRYLIC LIQUID, 1OZ ACRYLIC POWDER AND 112 CROWN SHELLS SIZES 1-16 OPAQUE
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
D752AK3PrimaryHIBCC0
D752AKUnit of UseHIBCC0

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
114
Kit
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D752AKT3DIRECTCROWNAKT2016-09-01
D752AP3DIRECTCROWNAP2016-09-01
D752AT3DIRECTCROWNAT2016-09-01
D752COMPBO1DIRECTCROWNCOMPBO2016-09-01
D752DC2AK3DIRECTCROWNDC2AK2016-09-01
D752DC2PK3DIRECTCROWNDC2PK2016-09-01
D752DL1DIRECTCROWNDL2016-09-01
D752DP1DIRECTCROWNDP2016-09-01
D752DP21DIRECTCROWNDP22016-09-01
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
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