“Titanium brush” is a generic name. Several manufacturers sell rotary brushes for the debridement of implant surfaces, and a study, a tender or a catalogue may use the generic term for any of them. The points below are what a clinician or a purchasing department can verify for any device before choosing one. For each point we state where the NiTi Brush from HANS Korea stands, with the page on this site where the evidence is kept. We do not comment on other manufacturers’ products; check the same points with their documentation.
The checklist ten points, each verifiable
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What are the bristles made of?
Why it matters. The bristle has to reach into the implant thread and wipe the surface without cutting it. Stiffness decides that: the lower the modulus of elasticity, the more the bristle bends along the thread instead of scraping across it.
NiTi Brush. Shape-memory nickel-titanium (Ni-Ti) alloy wire, about 0.095 mm in diameter. Modulus of elasticity about 28 GPa against about 115 GPa for titanium and 210 GPa for stainless steel, at comparable hardness (Vickers 303–362). Raw material →
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Do published studies name the device?
Why it matters. A paper that says only “a titanium brush” may have used any manufacturer’s instrument. Evidence counts for a device only when the paper identifies it.
NiTi Brush. 20 peer-reviewed publications identify the instrument as the NiTi Brush or name HANS Korea — randomised controlled trials (including multicentre), retrospective analyses, case series, in-vitro studies and reviews; 72 investigators at 35 institutions in 14 countries; 513 patients and at least 689 implants followed 6–42 months. Every entry carries its DOI. Published studies → · How the figures are counted →
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What is the regulatory status, with numbers you can look up?
Why it matters. A rotary instrument that touches an implant inside a surgical site is a medical device. Ask for the CE certificate number, the notified body, the class, the EU authorised representative and, for the USA, the FDA listing — and note that FDA registration and listing is not FDA approval or clearance.
NiTi Brush. CE marked, Class IIa, certificate 2195-MED-1734601 (notified body SZUTEST), validity extended under Regulation (EU) 2023/607 to 31 December 2028; EU authorised representative Eunitor GmbH, Düsseldorf; manufacturer SRN KR-MF-000018237. USA: FDA establishment registration and device listing D122465, product code DZA, 510(k)-exempt. GMDN 57955. Regulatory details →
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Is there an Instructions for Use document in your language?
Why it matters. The IFU is the document that governs use, and in the European Union a device may only be supplied in a country with an IFU in that country’s official language. The languages a manufacturer has published therefore show in which markets the device can lawfully be placed — a question for the distributor and the purchasing department, while the clinician only needs the one edition they read.
NiTi Brush. IFU document HKIFU-001, Rev. 07 (22 May 2023), published in 19 European languages, so the instrument can be supplied across the EU and EEA without waiting for a translation. Instructions for Use →
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Which drive and which speed does the manufacturer specify?
Why it matters. Too fast, and bristles fatigue or heat the site; too slow, and debridement is incomplete. The drive, the reduction ratio and the speed range should be printed.
NiTi Brush. Implant motor through a 20:1 reduction handpiece, 600–1,200 rpm, with extensive external sterile saline irrigation. Not for a turbine or a straight handpiece. Treatment protocol →
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Single use? How is it supplied, and how is it sterilised?
Why it matters. Bristles deform and carry debris after one surgical use. The label should say whether the brush is single-use and, if supplied non-sterile, give the sterilisation parameters.
NiTi Brush. Single use only. Supplied non-sterile; autoclave at 134 °C for 15 minutes before use. Intended use and safety →
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Does the range cover the defect you treat?
Why it matters. An initial lesion with one exposed thread, an established pocket with two or three, a deep defect, a narrow posterior site and a patient with limited opening each need a different head and shaft.
NiTi Brush. Four models — NANO (pointed, bound tip), POCKET (open head), POCKET SHORT (same head, 30 mm instead of 35 mm overall), OMEGA (wide, splayed head) — on the same shaft diameter. Model line-up and selection table →
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Who is the manufacturer, and can you reach them?
Why it matters. Traceability: a named legal manufacturer with an address, a contact and a history behind the product, and authorised distributors you can verify with them.
NiTi Brush. HANS KOREA CO.,Ltd., Paju, Republic of Korea, developing the instrument since 2010; three granted Korean patents, first filed November 2011; distributors in 18 countries, confirmed on request. Company → · Contact →
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Can you see the surface result?
Why it matters. The purpose of the instrument is a decontaminated, smoothed surface with the thread geometry preserved. Ask for before-and-after images and microscopy.
NiTi Brush. Intra-operative before/after pairs, removed implants debrided in the laboratory, scanning electron microscopy at ×10,000 and CBCT before and after bone regeneration. Clinical cases → · Image gallery →
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Is there a protocol, and can you watch the technique?
Why it matters. The brush is one step in a sequence — diagnosis, brush selection, sterilisation, mechanical debridement, adjunctive chemical treatment, regeneration.
NiTi Brush. A six-step treatment protocol, a literature summary of the chemical adjuncts used after brushing in published reports, and technique videos. Protocol → · Chemical adjuncts after brushing → · Videos →
How to be sure it is the NiTi Brush
The packaging and the Instructions for Use name NiTi Brush and HANS KOREA CO.,Ltd., and the IFU carries the document number HKIFU-001. Similar devices from other manufacturers carry their own names and documents. If you are unsure whether a supplier is an authorised distributor, write to [email protected] with the supplier’s name and country and we will confirm.
Frequently asked
Are all titanium brushes the same?
No. The generic name covers rotary brushes from several manufacturers that differ in bristle alloy, head geometry, specified drive and speed, regulatory documentation and the evidence that names them. The checklist above is a way to compare them point by point.
Is the NiTi Brush a titanium brush?
Yes, in the generic sense: it is a rotary brush with titanium-alloy bristles for implant surface debridement. Its bristles are nickel-titanium, a shape-memory alloy, rather than pure titanium.
How many published studies name the NiTi Brush?
Twenty peer-reviewed publications identify the instrument as the NiTi Brush or name HANS Korea. The list, with DOIs, is on the Literature page and is available as a downloadable dataset.