FDA.reportPublic FDA data

3.25 x 13 Simpler One Push in Implant HA

Primary DI
D780S150030
Brand
3.25 x 13 Simpler One Push in Implant HA
Company
Simpler Implant Solutions Inc
Model
S1 5003
Catalog number
S1 5003
Device description
3.5mm Diameter x 13mm length Simpler One Surgery Two Piece Hydroxylapatite (HA) coated Push in implant
Published
2015-10-24
Public version status
Update
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
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D780S150030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
203213343
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7800603766 x 13mm Simpler Threaded Dental Implant ST 3023ST 30232015-11-13
D780302206 x 10mm Simpler Threaded Dental Implant ST 3022ST 30222015-11-13
D780S0S331003.0mm x 10mm MaxiMini Dental Implant SOS 3310SOS 33102015-10-24
D780S0S5531Simpli MaxiMini HA Implants S0S 5515S0S 55152015-10-24
D780S0S560806 x 8mm Simpli MaxiMini HA Coated Dental Implants S0S 5608S0S 56082015-11-13
D780S1500203.5 x 10 Simpler One Push in Implant HA S1 5002 S1 5002 2015-10-24
D780S1500403.25mm x 15mm Simpler One Push in Implant HA S1 5004S1 5004 2015-10-24
D780S1500504.0mm x 8mm Simpler One Push in Dental Implant HA S1 5005S1 5005 2015-10-24
D780S1500604.0mm x 10mm Simpler One Push in Implant HA S1 5006S1 50062015-10-24
D780S1500703.25mm x 13mm Simpler One Push in Implant HA S1 5007S1 50072015-10-24
D780S1500804.0mm x 15mm Simpler One Push in Implant HA S1 5008S1 50082015-10-24
D780S1S331003 x 10mm Simpli Simpler One Piece Dental Implant S1S 3310S1S 33102015-11-06
D780S1S331303x13mm Simpli Simpler One Piece GBAE Dental Implant S1S 3313S1S 33132015-11-06
D780S1S331503 x 15mm Simpli Simpler One Piece GBAE Dental Implant S1S 3315S1S 33152015-11-06
D780S1S340804.0 x 8 Simpli Simpler One Piece GBAE Dental Implant S1S 3408S1S 34082015-11-06
D780S1S341004 x 10mm Simpli Simpler One Piece GBAE Dental Implant S1S 3410S1S 34102015-11-06
D780S1S341304 x 13 mm Simpli Simpler One Piece GBAE Dental Implant S1S 3413S1S 34132015-11-06
D780S1S341504.0 x 15mm Simpli Simpler One Piece GBAE Dental ImplantS1S 3415S1S 3415 2015-11-06
D780S1S350805x8 Simpli Simpler One Piece GBAE Dental Implants S1S 3508S1S 35082015-11-06
D780S1S351005 x 10mm Simpli Simpler One Piece GBAE Dental Implant S1S 3510S1S 35102015-11-06

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Primary DI, Brand, Company table
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