FDA.reportPublic FDA data

s-Clean ScanHealing Abutment

Primary DI
08800053071895
Brand
s-Clean ScanHealing Abutment
Company
DENTIS CO. ,LTD
Model
DSSHM4860
Device description
s-Clean ScanHealing Abutment (DSSHM4860)
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K241063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241063000s-Clean ScanHealing AbutmentDentis Co., Ltd.2024-07-25NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053071895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053071895088000530718958800053071895

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694721181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800313235715SQ AXEL Guide CountersinkDSAGCS502026-07-09
08800313235722SQ AXEL Guide CountersinkDSAGCS462026-07-09
08800313235739SQ AXEL Guide CountersinkDSAGCS422026-07-09
08800313235746SQ AXEL Guide CountersinkDSAGCS382026-07-09
08800313235753SQ AXEL Guide Step DrillDSAGSTD50162026-07-09
08800313235760SQ AXEL Guide Step DrillDSAGSTD50142026-07-09
08800313235777SQ AXEL Guide Step DrillDSAGSTD50122026-07-09
08800313235784SQ AXEL Guide Step DrillDSAGSTD50102026-07-09
08800313235791SQ AXEL Guide Step DrillDSAGSTD50082026-07-09
08800313235807SQ AXEL Guide Step DrillDSAGSTD46162026-07-09
08800313235814SQ AXEL Guide Step DrillDSAGSTD46142026-07-09
08800313235821SQ AXEL Guide Step DrillDSAGSTD46122026-07-09
08800313235838SQ AXEL Guide Step DrillDSAGSTD46102026-07-09
08800313235845SQ AXEL Guide Step DrillDSAGSTD46082026-07-09
08800313235852SQ AXEL Guide Step DrillDSAGSTD42162026-07-09
08800313235869SQ AXEL Guide Step DrillDSAGSTD42142026-07-09
08800313235876SQ AXEL Guide Step DrillDSAGSTD42122026-07-09
08800313235883SQ AXEL Guide Step DrillDSAGSTD42102026-07-09
08800313235890SQ AXEL Guide Step DrillDSAGSTD42082026-07-09
08800313235906SQ AXEL Guide Step DrillDSAGSTD38162026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046888EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223758Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223796Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070224236Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224274Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27