FDA.reportPublic FDA data

i-Clean Angled Abutment

Primary DI
08806169166401
Brand
i-Clean Angled Abutment
Company
DENTIS CO. ,LTD
Model
DIAA25S
Device description
Dental Implant Abutment / i-Clean Angled Abutment / DIAA25S
Published
2022-11-14
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
HNASpud, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082843000MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEMDentis Co., Ltd.2009-06-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806169166401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806169166401088061691664018806169166401

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056111322123SurtexSURTEX INSTRUMENTS LTD.HNA2026-05-12
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00194613004521MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005344MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005351MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005368MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613030643MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613091859MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121792MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121969MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
G412PH60920MR PHACOCrestpoint Management LimitedHNA2025-06-07
G412PH60930MR PHACOCrestpoint Management LimitedHNA2025-06-07
00194613005337MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613005375MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613021139MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613039899MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613053932MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00757770408993Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770414284Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770418893Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
G586OP7125400Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
G586OP7125540Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
00190776355371MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776355388MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776069575AvalignAvalign Technologies, Inc.HNA2023-06-23
G2231108400Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNA2023-06-08
14026704799395PILLINGTELEFLEX INCORPORATEDHNA2022-12-08
14026704799401PILLINGTELEFLEX INCORPORATEDHNA2022-12-08