FDA.report

Pylon Sleeve

Primary DI
08800076461291
Brand
Pylon Sleeve
Company
Truabutment Korea Co.,Ltd
Model
SPRC38
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
08800076461291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800076461291088000764612918800076461291

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694514760
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

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08800076409989Impression Post Pick-Up Type ScrewUIPPNS152026-03-24
08800076409996Impression Post Pick-Up Type ScrewUIPPNS192026-03-24
08800076410008Impression Post Pick-Up Type ScrewUIPPNS212026-03-24
08800076410015Impression Post Pick-Up Type ScrewUIPPNS252026-03-24
08800076410022Impression Post Pick-Up Type ScrewUIPPS162026-03-24
08800076410039Impression Post Pick-Up Type ScrewUIPPS202026-03-24
08800076410046Impression Post Pick-Up Type ScrewUIPPS222026-03-24
08800076410053Impression Post Pick-Up Type ScrewUIPPS262026-03-24
08800076414440AOT Digital AnalogCMM-ATDLA2026-03-24
08800076414662Multi-Unit Burn Out CylinderUMBC50H2026-03-24
08800076414679Multi-Unit Burn Out CylinderUMBC50N2026-03-24
08800076418073Drill ExtensionDEH45142026-03-24
08800076423664URIS Scan PostUSPN40182026-03-24
08800076423671URIS Scan PostUSPN40282026-03-24
08800076423688URIS Scan PostUSPN40382026-03-24
08800076423695URIS Scan PostUSPR45082026-03-24
08800076423701URIS Scan PostUSPR45182026-03-24
08800076423718URIS Scan PostUSPR45282026-03-24
08800076423725URIS Scan PostUSPR45382026-03-24
08800076423756TruScan Post Kit CaseBHN-SBCASE2026-03-24

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
08800076409989Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076409996Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410008Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410015Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410022Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410039Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410046Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076410053Impression Post Pick-Up Type ScrewTruabutment Korea Co.,LtdNDP2026-03-24
08800076414440AOT Digital AnalogTruabutment Korea Co.,LtdNDP2026-03-24
08800076414662Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076414679Multi-Unit Burn Out CylinderTruabutment Korea Co.,LtdNDP2026-03-24
08800076418073Drill ExtensionTruabutment Korea Co.,LtdNDP2026-03-24
08800076423664URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423671URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423688URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423695URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423701URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423718URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24
08800076423725URIS Scan PostTruabutment Korea Co.,LtdNDP2026-03-24