FDA.report

SD Abutment

Primary DI
08800041005833
Brand
SD Abutment
Company
Surgident Co.,Ltd.
Model
PAA-651515N
Catalog number
AA-651515N
Published
2019-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800041005833PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
689846448
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800041065691Easy Bone Expander KitSD-EBE2023-10-25
08800041065714P.R.P MEMBRANE KITME-PRP2023-10-25
08800041065721POWERTOME KITSD-EXM2023-10-25
08800041065738Implant Removal Kit Gen IISD-SO2023-10-25
08800041065745Screw Fixation KitME-SCRT2023-10-25
08800041065752Drill Stop KitME-SD2023-10-25
08800041065769Shatkin F.I.R.S.T Sinus Lift KitSD-EBE2023-10-25
08800041065776Contra TorqueME-TQ2023-10-25
08800041065783System of Torque DriverSD-STOQ2023-10-25
08800041065790SD Bone ProfilerBP37452023-10-25
08800041065813Ridge Expansion KitME-EBE2023-10-25
08800041065684Dr. Sam Lee Basic setSL-BK2023-10-24
08800041065707P.R.F SYSTEMSD-PRF2023-10-24
08800041038121MalletMT-4142023-10-18
08800041039128Tac Remover DriverTR- 022023-10-18
08800041039135Tac ApplicatorTR-032023-10-18
08800041039807Tac Remover DriverTR-012023-10-18
08800041044214Pilot DrillSD-PD122023-10-18
08800041044221Pilot DrillSD-PD142023-10-18
08800041044238Pilot DrillSD-PD182023-10-18

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07290120482470IH Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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07290120486874RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
07290120486928RP Straight Multi-Unit AbutmentSURCAM - MEDICAL DEVICES AND DEVELOPMENTS LTDNHA2026-03-24
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