DSI

Primary DI
D9560MUSRP30
Brand
DSI
Company
D.S.I DENTAL SOLUTIONS LTD
Model
MU-S-RP-30
Device description
Premium Straight Multi-Unit Abutment 3mm
Published
2021-04-27
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
K200188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200188000DSI Dental Implant SystemDsi Dental Solutions, Ltd.2020-04-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9560MUSRP30PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532290720
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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D9560SILFLO5Sil-FlowSILFLO52025-06-26
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D9560000ULA1UniLite Universal Composite 4g A1UL-A12024-06-26
D9560000ULA2UniLite Universal Composite 4g A2UL-A22024-06-26
D9560000ULA3UniLite Universal Composite 4g A3UL-A32024-06-26
D9560000ULB1UniLite Universal Composite 4g B1UL-B12024-06-26
D9560000ULB2UniLite Universal Composite 4g B2UL-B22024-06-26
D9560000ULB3UniLite Universal Composite 4g B3UL-B32024-06-26
D956000ULA35UniLite Universal Composite 4g A3.5UL-A352024-06-26
D956000ULUD0UniLite Universal Composite 4g Opaque UniversalUL-UD2024-06-26
D956000USP800UltraSil Putty 800US-P8002024-06-26
D95600ULFNA0UniLite Flow 2 x 2g Bleach A0ULFN-A02024-06-26
D95600ULFNA1UniLite Flow 2 x 2g Composite A1ULFN-A12024-06-26
D95600ULFNA2UniLite Flow 2 x 2g Composite A2ULFN-A22024-06-26
D95600ULFNA3UniLite Flow 2 x 2g Composite A3ULFN-A32024-06-26
D95600ULFNB1UniLite Flow 2 x 2g Composite B1ULFN-B12024-06-26
D95600ULFNB2UniLite Flow 2 x 2g Composite B2ULFN-B22024-06-26
D95600ULFNB3UniLite Flow 2 x 2g Composite B3ULFN-B32024-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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