DSI

GUDID D956000SOD15

Standard Overdenture 1.5mm

D.S.I DENTAL SOLUTIONS LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system
Primary Device IDD956000SOD15
NIH Device Record Keycb774414-b7bc-4904-bf22-b128a5f9b165
Commercial Distribution StatusIn Commercial Distribution
Brand NameDSI
Version Model NumberSOD15
Company DUNS532290720
Company NameD.S.I DENTAL SOLUTIONS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD956000SOD15 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

[D956000SOD15]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-05
Device Publish Date2021-04-27

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D9560SPI1635Premium Spiral Implant 3.5 x 16 mm
D9560SPI1338Premium Spiral Implant 3.75 x 13 mm
D9560SPI1335Premium Spiral Implant 3.5 x 13 mm
D9560SPI1138Premium Spiral Implant 3.75 x 11.5 mm
D9560SPI1135Premium Spiral Implant 3.5 x 11.5 mm
D9560SPI1038Premium Spiral Implant 3.75 x 10 mm
D9560SPI1035Premium Spiral Implant 3.50 x 10mm
D9560SPI0838Premium Spiral Implants 3.75 x 8 mm
D9560SPI0835Premium Spiral Implant 3.5 x 8 mm
D9560STAA253Anatomic Angulated 25 Degree Abutment 3mm Collar
D9560STAA252Anatomic Angulated 25 Degree Abutment 2mm Collar
D9560STAA251Anatomic Angulated 25 Degree Abutment 1mm Collar
D9560STAA153Anatomic Angulated 15 Degree Abutment 3mm Collar
D9560STAA152Anatomic Angulated 15 Degree Abutment 2mm Collar
D9560STAA151Anatomic Angulated 15 Degree Abutment 1mm Collar
D9560SPI1650Premium Spiral Implant 5.00 x 16 mm
D9560SPI1642Premium Spiral Implant 4.2 x 16 mm
D9560SPI1350Premium Spiral Implant 5.00 x 13 mm
D9560SPI1342Premium Spiral Implant 4.2 x 13 mm
D9560SPI1160Premium Spiral Implant 6.00 x 11.5 mm
D9560SPI1150Premium Spiral Implant 5.00 x 11.5 mm
D9560SPI1142Premium Spiral Implant 4.2 x 11.5 mm
D9560SPI1060Premium Spiral Implant 6.00 x 10 mm
D9560SPI1050Premium Spiral Implant 5.00 x 10 mm
D9560SPI1042Premium Spiral Implant 4.2 x 10mm
D9560SPI0860Premium Spiral Implants 6.00 x 8 mm
D9560SPI0850Premium Spiral Implants 5.00 x 8 mm
D9560SPI0842Premium Spiral Implant 4.2 x 8 mm
D9560MUSRP40Premium Straight Multi-Unit Abutment 4mm
D9560MUSRP30Premium Straight Multi-Unit Abutment 3mm
D9560MUSRP20Premium Straight Multi-Unit Abutment 2mm
D9560MUSRP10Premium Straight Multi-Unit Abutment 1mm
D95600STWA11Straight Wide Abutment 11mm
D95600STSWA3Straight Wide Shoulder Abutment 3mm
D95600STSWA2Straight Wide Shoulder Abutment 2mm
D95600STSWA1Straight Wide Shoulder Abutment 1mm
D95600STNA11Straight Narrow Abutment 11mm
D95600SHCXW5Extra Wide Healing Cap 6.3 x 5mm
D95600SHCXW4Extra Wide Healing Cap 6.3 x 4mm
D95600SHCXW3Extra Wide Healing Cap 6.3 x 3mm
D95600SHCXW2Extra Wide Healing Cap 6.3 x 2mm
D95600LIRP60Loc-In Premium Straight Abutment 6mm
D95600LIRP50Loc-In Premium Straight Abutment 5mm
D95600LIRP40Loc-In Premium Straight Abutment 4mm
D95600LIRP30Loc-In Premium Straight Abutment 3mm
D95600LIRP20Loc-In Premium Straight Abutment 2mm
D95600LIRP10Loc-In Premium Straight Abutment 1mm
D95600LIRP05Loc-In Premium Straight Abutment 0.5mm
D956000STWA9Straight Wide Abutment 9mm
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