FDA.reportPublic FDA data

Surtex

Primary DI
07350081495596
Brand
Surtex
Company
Dentatus AB
Model
SST-18
Catalog number
SST-18
Device description
Surtex Stainless Steel Post Dispenser Intro Kit - 18 Posts/Kit plus Accessories - Sizes: Short #1 and #2, Medium #1, #4, #5 and #6, Long #1 to #6, Extra Long #4 and #6 - 1 of Each, Sizes: Medium #2 and #3 - 2 of Each - Accessories: Classic Standard Stainless Steel Reamers - Sizes: Short #1 to #6 - Cross Key and Hollow Key - Silicon Length Stoppers
Published
2025-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral
EJBHandle, Instrument, Dental
ELRPost, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
EJBHandle, Instrument, DentalDental1
ELRPost, Root CanalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350081495596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081495596073500814955967350081495596

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Liquid Chemical

Regulatory Flags#

DUNS number
355803412
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081492335SurtexRST-18RST-182025-01-30
07350081495602SurtexTST-18TST-182025-01-30
07350081490515Lamineer TipsLTA-100/2LTA-100/22025-01-28
07350081490539Lamineer TipsLTA-15/2LTA-15/22025-01-28
07350081490553Lamineer TipsLTA-150/2LTA-150/22025-01-28
07350081490577Lamineer TipsLTA-30/2LTA-30/22025-01-28
07350081490591Lamineer TipsLTA-39/2LTA-39/22025-01-28
07350081490621Lamineer TipsLTA-50/2LTA-50/22025-01-28
07350081490645Lamineer TipsLTA-75/2LTA-75/22025-01-28
07350081490669Lamineer TipsLTA-C50/2LTA-C50/22025-01-28
07350081490683Lamineer TipsLTA-D100/2LTA-D100/22025-01-28
07350081490706Lamineer TipsLTA-D150/2LTA-D150/22025-01-28
07350081490720Lamineer TipsLTA-D30/2LTA-D30/22025-01-28
07350081490751Lamineer TipsLTA-D50/2LTA-D50/22025-01-28
07350081490775Lamineer TipsLTA-E50/2LTA-E50/22025-01-28
07350081490898Lamineer TipsLTA-S100/2LTA-S100/22025-01-28
07350081490911Lamineer TipsLTA-S15/2LTA-S15/22025-01-28
07350081490935Lamineer TipsLTA-S150/2LTA-S150/22025-01-28
07350081490959Lamineer TipsLTA-S30/2LTA-S30/22025-01-28
07350081490973Lamineer TipsLTA-S36/2LTA-S36/22025-01-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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