FDA.reportPublic FDA data

i-Clean Gold UCLA Abutment Set

Primary DI
08800053080392
Brand
i-Clean Gold UCLA Abutment Set
Company
DENTIS CO. ,LTD
Model
DIGUNS
Device description
Dental Implant System / i-Clean Gold UCLA Abutment Set
Published
2022-12-09
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171027000Dentis Dental Implant SystemDentis Co., Ltd.2017-09-06DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053080392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053080392088000530803928800053080392

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694721181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313236132SQ AXEL Step DrillDSASTD54122026-05-08
08800053007115i-Clean Solid Abutment DriverDSADS2026-04-22
08800053007122i-Clean Solid Abutment DriverDSADL2026-04-22
08800053023757Bone ProfilerDBP452026-04-22
08800053023764Bone ProfilerDBP552026-04-22
08800053023771Bone ProfilerDBP652026-04-22
08800053032322Bone Profiler BaseDBPBN2026-04-22
08800053032339Bone Profiler BaseDBPBM2026-04-22
08800053032346Bone Profiler BaseDBPBR2026-04-22
08800053034340Surgical SQ KITDSQKN-12026-04-22
08800053038737I-FIX Angled Mount Adapter BodyDNAMB2026-04-22
08800053038744I-FIX Angled Mount Adapter ScrewDNAMS2026-04-22
08800053038751I-FIX Angled Mount AdapterDNAMA2026-04-22
08800053042505I-FIX Bone ProfilerDBPI402026-04-22
08800053043526SQ Guide Profiler DrillDSQGPDM2026-04-22
08800053081030Depth GaugeDSSDGN2026-04-22
08800053081047Bone PackerDSSBPN2026-04-22
08800053081054SAVE 03DSSS03N2026-04-22
08800053083041ReamerDSSR28N2026-04-22
08800053083058ReamerDSSR31N2026-04-22

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