FDA.reportPublic FDA data

4x13mm Simpli MaxiMini HA ORing Implants

Primary DI
D780SOS54130
Brand
4x13mm Simpli MaxiMini HA ORing Implants
Company
Simpler Implant Solutions Inc
Model
SOS 5413
Catalog number
SOS 5413
Device description
Simpli Simpler O Ring hydroxylapatite (HA) coating One Piece dental implants
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
D780SOS54130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-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 one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) 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
Microwave Radiation

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
D780S1500303.25 x 13 Simpler One Push in Implant HA S1 5003S1 50032015-10-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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