FDA.report

Diamodent

Primary DI
D907AK1000
Brand
Diamodent
Company
DIAMODENT INC
Model
N/A
Catalog number
AK100
Device description
Compatible with: 4.1mm Platform Internal BIOMET 3i Certain implants UCLA Abutment, Gold/Clear Plastic, Blue Hexed, 0.5mm Collar, 4.5mm Profile, Titefit
Published
2019-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D907AK1000PrimaryHIBCC0

GMDN Terms

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
Dry Heat Sterilization

Regulatory Flags

DUNS number
013827410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D907BV9101DiamoDentN/ABV9102023-10-27
D907BW9101DiamoDentN/ABW9102023-10-27
D907AA7550DiamoDentN/AAA7552023-08-16
D907AB7050DiamoDentN/AAB7052023-08-16
D907AB7550DiamoDentN/AAB7552023-08-16
D907AP10100DiamoDentN/AAP10102023-08-16
D907AS10100DiamoDentN/AAS10102023-08-16
D907AS10110DiamoDentN/AAS10112023-08-16
D907T53200DiamoDentN/AT5320-62023-08-16
D907T54910DiamoDentN/AT54912023-08-16
D907T54930DiamoDentN/AT54932023-08-16
D907BB9101DiamoDentN/ABB9102022-04-15
D907BC9101DiamoDentN/ABC9102022-04-15
D907BD9101DiamoDentN/ABD9102022-04-15
D907AJ10100DiamoDentN/AAJ10102022-04-14
D907AJ10110DiamoDentN/AAJ10112022-04-14
D907AJ8000DiamoDentN/AAJ8002022-04-14
D907AJ8010DiamoDentN/AAJ8012022-04-14
D907BA9000DiamoDentN/ABA9002022-04-14
D907AJ1000DiamoDentN/AAJ1002022-04-13

Other Devices Sharing Product Codes

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08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
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08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20