FDA.reportPublic FDA data

DiamoDent

Primary DI
D907BB9100
Brand
DiamoDent
Company
DIAMODENT INC
Model
N/A
Catalog number
BB910
Device description
IMPLANT REPLICA, Aluminum, Purple3.5mm (NP) Nobel Active & Replace Conical ConnectionNobel Biocare Implants
Published
2022-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D907BB9101PackageHIBCC6In Commercial Distribution
D907BB9102PackageHIBCC12In Commercial Distribution
D907BB9100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
013827410
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D907AA7550DiamoDentN/AAA7552023-08-16
D907AB7050DiamoDentN/AAB7052023-08-16
D907AB7550DiamoDentN/AAB7552023-08-16
D907AS10100DiamoDentN/AAS10102023-08-16
D907AS10110DiamoDentN/AAS10112023-08-16
D907BV9100DiamoDentN/ABV9102023-10-27
D907BW9100DiamoDentN/ABW9102023-10-27
D907BV9101DiamoDentN/ABV9102023-10-27
D907BW9101DiamoDentN/ABW9102023-10-27
D907T57000DiamodentN/AT57002018-12-28
D907T57100DiamodentN/AT57102018-12-28
D907T57200DiamodentN/AT57202018-12-28
D907T57300DiamodentN/AT57302018-12-28
D907AP10100DiamoDentN/AAP10102023-08-16
D907T53200DiamoDentN/AT5320-62023-08-16
D907T54910DiamoDentN/AT54912023-08-16
D907T54930DiamoDentN/AT54932023-08-16
D907T55800DiamodentN/AT55802018-12-31
D907BC9100DiamoDentN/ABC9102022-04-15
D907BD9100DiamoDentN/ABD9102022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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