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Straumann Tibrush

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
STRAUMANN TIBRUSH FDA UDI
Generic Name
Dental implant/teeth debridement brush, non-biodegradable FDA UDI
Device Name
Straumann® TiBrush, titanium, stainless steel FDA UDI
Model / Reference
1 FDA UDI
Description
Straumann® TiBrush, titanium, stainless steel FDA UDI

Identifiers

Catalog Number
070.005 FDA UDI
Primary DI / UDI-DI
07630031726780 FDA UDI
510(k) Number
K111724 FDA UDI
FDA Product Code
ELB FDA UDI
GMDN Term
Dental implant/teeth debridement brush, non-biodegradable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental implant/teeth debridement brush, non-biodegradable

Straumann Tibrush by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant/teeth debridement brush, non-biodegradable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann SA

Sources (1)

  • FDA UDI 29f6aa48-3470-4d67-9150-130178e9e299 36 fields · synced Jun 8, 2026