Surtex

FDA UDI

Class I (US FDA UDI)

by Dentatus AB

Identity

Trade Name: Surtex FDA UDI
Generic Name: Steel dental bur, reusable FDA UDI
Device Name: Surtex Gold Plated Post Dispenser Starter Kit - 60 Posts/Kit plus Accessories - Post Material: Brass Core with Gold Plating - Sizes: Short #1 to #6, Medium #1 to #6, Long #1 to #6, Extra Long #4 and #6 - Accessories: Classic Standard Stainless Steel Reamers - Sizes: Short #1 to #6 - Cross Key and Hollow Key - Silicon Length Stoppers FDA UDI
Model / Reference: RST-60 FDA UDI
Description: Surtex Gold Plated Post Dispenser Starter Kit - 60 Posts/Kit plus Accessories - Post Material: Brass Core with Gold Plating - Sizes: Short #1 to #6, Medium #1 to #6, Long #1 to #6, Extra Long #4 and #6 - Accessories: Classic Standard Stainless Steel Reamers - Sizes: Short #1 to #6 - Cross Key and Hollow Key - Silicon Length Stoppers FDA UDI

Identifiers

Catalog Number: RST-60 FDA UDI
Primary DI / UDI-DI: 07350081492342 FDA UDI
FDA Product Code: ELR FDA UDI
DZA FDA UDI
EJB FDA UDI
GMDN Term: Steel dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3810 FDA UDI
872.4130 FDA UDI
872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Steel dental bur, reusable Root canal post, preformed

Surtex by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dentatus AB

Sources (1)

FDA UDI ca157685-c0ec-4dd2-9220-81f0640a9153 34 fields · synced May 31, 2026