Is the FDA 510(k) yours?

Not yet. Ruten's own FDA 510(k) is in preparation, with submission expected in 2027. In the meantime, overseas clearance documents are available for verification at quotation stage.

Can it be used on children?

That should be a clinician's decision. The format is small and the temperature rise is low, but paediatric use still needs professional assessment.

Zeolite · VolcanoShield

Zeolite Hemostatic Cotton Ball 0.3 g

Name: Zeolite Hemostatic Cotton Ball 0.3 g
Brand: Ruten Medical
SKU: RT-ZEO-CB03
Availability: InStock

Model: RT-ZEO-CB03

Fine hemostasis for oral and superficial wounds

A 0.3 g zeolite cotton ball for dental extraction, oral surgery, and superficial wounds. Overseas clearance documents and product standards are supplied at quotation stage.

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Zeolite Hemostatic Cotton Ball 0.3 g (RT-ZEO-CB03) - Ruten Medical

Zeolite · VolcanoShieldMaterial platform

Key Specifications

Part no.RT-ZEO-CB03

Fill weight0.3 g

FormatCotton-ball format

IndicationOral and superficial wounds

Overseas clearanceDocuments on request

Mechanism

Why it controls this kind of bleeding

The cotton-ball format is easy to place and retrieve in confined spaces such as the mouth. Zeolite draws water and concentrates clotting factors to form a local clot, and is removed afterwards as usual.

Product Features

Fine 0.3 g format
Suited to dentistry and oral surgery
Easy to place and retrieve
Overseas clearance docs on request

Applications

Where it is used

Post-extraction bleeding

Oral surgery

Superficial wounds

Minor office bleeding

Specification & Ordering

Models, packaging and supply

Part no.	RT-ZEO-CB03
Fill weight	0.3 g
Format	Cotton-ball format
Indication	Oral and superficial wounds
Overseas clearance	Documents on request
Registration	Domestic Class II device registration (granted 2022); number and scan supplied at quotation stage
Packaging & supply	0.3 g cotton-ball format, individually packed and supplied by carton.
Deliverable Dossier	Batch COA, ISO 13485 QMS certificate, ISO 10993 biocompatibility summary, bilingual IFU, and export clearance documents (Commercial Invoice, Packing List, HS Code / SDS support) supplied at quotation.