FDA.report

Point Drill

Primary DI
08800041044146
Brand
Point Drill
Company
Surgident Co.,Ltd.
Model
GPD50
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800041044146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800041044146088000410441468800041044146

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
689846448
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055791203NB Master KitARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055791210NB Regular Kit ARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792774Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792781Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792798Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792804Fixture Driver MachineARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792910Torque ExtensionARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792958Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792965Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792972Trial PinARUM DENTISTRY Co., Ltd.NDP2026-03-24
08800055792996Torque RatchetARUM DENTISTRY Co., Ltd.NDP2026-03-24
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