FDA.reportPublic FDA data

s-Clean Temporary Abutment Mini

Primary DI
08800053033121
Brand
s-Clean Temporary Abutment Mini
Company
DENTIS CO. ,LTD
Model
DSPTM553N
Device description
Dental Implant System / s-Clean Temporary Abutment Mini (DSPTM553N)
Published
2022-06-27
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
K210080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210080000Dentis s-Clean s-Line MiniDentis Co., Ltd.2021-06-04DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800053033121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800053033121088000530331218800053033121

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
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
08800313235241ScanTarget KITDSCTK2026-09-21
08800313235296ScanTargetDSCTL2026-09-21
08800313235302ScanTargetDSCTM2026-09-18
08800313235319ScanTargetDSCTS2026-09-18
08800313235326MU Gingival ScanBodyDSMUGSBF2026-09-18
08800313235425ScanTarget Bite CapDSCTBC42026-09-18
08800313235432ScanTarget Bite CapDSCTBC22026-09-18
08800313230017ChecQPEGDCQP272026-08-26
08800313230024ChecQPEGDCQP382026-08-26
08800313230031ChecQPEGDCQP502026-08-26
08800313230048ChecQPEGDCQP532026-08-26
08800313230055ChecQPEGDCQP542026-08-26
08800313230062ChecQPEGDCQP632026-08-26
08800313237429ChecQPEGDCQP322026-08-26
08800313237436ChecQPEGDCQP572026-08-26
08800313237443ChecQPEGDCQP482026-08-26
08800313237450ChecQPEGDCQP602026-08-26
08800313237467ChecQPEGDCQP012026-08-26
08800313237474ChecQPEGDCQP032026-08-26
08800313237481ChecQPEGDCQP282026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216473ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216480ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216497ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216503ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216589ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216596ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216619ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18