FDA.report

NA

Primary DI
07630031756718
Brand
NA
Company
Institut Straumann AG
Model
Non-invasive Instruments
Catalog number
025.2920-04
Device description
NC Polishing Aid, stainless steel
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630031711878PrimaryGS10
07630031756718Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630031711878076300317118787630031711878
07630031756718076300317567187630031756718

GMDN Terms

TermDefinition
Orthopaedic cement ultrasonic surgical system handpiece tip, single-useA removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut orthopaedic cement upon contact during an orthopaedic surgical procedure (e.g., revision hip arthroplasty); it is not intended to cut body tissues. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for cement debris aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags

DUNS number
483599259
Device count
4
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
07630031773258NAsurgically Invasive Instruments034.364S2026-03-14
07630031750853Straumann Cares Bone Level Screw Retained Bars / BridgesBridges (implant borne)010.12482026-03-04
07630031750860Straumann Cares Bone Level Screw Retained Bars / BridgesBridges (implant borne)010.12492026-03-04
07630031772718NAsurgically Invasive Instruments044.782S2026-03-04
07630031772725NAsurgically Invasive Instruments044.783S2026-03-04
07630031772732NAsurgically Invasive Instruments044.784S2026-03-04
07630031772749NAsurgically Invasive Instruments044.785S2026-03-04
07630031772756NAsurgically Invasive Instruments044.786S2026-03-04
07630031772763NAsurgically Invasive Instruments044.787S2026-03-04
07630031772770NAsurgically Invasive Instruments044.788S2026-03-04
07630031772787NAsurgically Invasive Instruments044.789S2026-03-04
07630031772794NAsurgically Invasive Instruments044.790S2026-03-04
07630031772800NAsurgically Invasive Instruments044.791S2026-03-04
07630031772817NAsurgically Invasive Instruments044.792S2026-03-04
07630031772824NAsurgically Invasive Instruments044.793S2026-03-04
07630031772831NAsurgically Invasive Instruments044.794S2026-03-04
07630031772848NAsurgically Invasive Instruments044.795S2026-03-04
07630031772855NAsurgically Invasive Instruments044.796S2026-03-04
07630031772862NAsurgically Invasive Instruments044.797S2026-03-04
07630031772879NAsurgically Invasive Instruments066.1101S2026-03-04

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