FDA.reportPublic FDA data

Diamodent

Primary DI
D907K2010
Brand
Diamodent
Company
DIAMODENT INC
Model
N/A
Catalog number
K201
Device description
Compatible with: 5.0mm External Hex Replace and HL Threaded Steri-Oss implantsUCLA Abutment, Clear Plastic Non-Hexed, 1.3mm Collar, 5.4mm Profile
Published
2019-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010619000UCLA AND UNIVERSAL ABUTMENTSDiamodent2001-09-28DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D907K2010PrimaryHIBCC0

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
D907BB9100DiamoDentN/ABB9102022-04-15
D907BC9100DiamoDentN/ABC9102022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203347ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203361ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203385ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800075200051I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200068I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200075I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200082I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200099I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200105I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200112I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200129I DoOneday Biotech Co.,Ltd.DZE2026-06-04
08800075200136I DoOneday Biotech Co.,Ltd.DZE2026-06-04