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Kagayaki

SEIKA-STRIP

Seika Strip Dental Finishing and Polishing Strips

Dental Abrasive Strips

General Information

Seika Strip dental finishing and polishing strips are single-use, non-sterile strips intended for professional dental use, supplied as individual pre-cut strips, each in its own primary packaging.

Of the five strip types, four are abrasive grades (Coarse, Medium, Fine, Extrafine) coated with aluminium oxide abrasive at a fixed grit. The fifth type, the Transparent Matrix strip, is non-abrasive and is used before light-curing to contour composite restorations interproximally.

Intended Purpose and Indications for Use

Seika Strip strips are intended for contouring, finishing and polishing of interproximal surfaces of composite, compomer and glass ionomer restorations, and for prophylactic cleaning of interproximal tooth surfaces.

The product is intended to be used by dental professionals only.

Strip Types and Abrasive Grades

  • Coarse — Blue — grit #280 — width 5 mm, thickness 75 µm
  • Medium — Green — grit #500 — width 5 mm, thickness 50 µm
  • Fine — Grey — grit #800 — width 5 mm, thickness 45 µm
  • Extrafine — Pink — grit #1200 — width 5 mm, thickness 40 µm
  • Transparent Matrix strip — non-abrasive — width 8 mm, thickness 50 µm

For best results, use the abrasive strips progressively from coarser to finer grades.

Contraindications and Possible Side Effects

Do not use the product on patients with a known allergy or hypersensitivity to aluminium oxide or to any other product material.

Hypersensitivity or other adverse reactions to abrasive strip materials have been reported for similar dental products. If signs of such a reaction appear during or after use, stop the procedure and advise the patient to seek medical attention.

No other side effects specific to this product have been identified at this time.

Warnings and Precautions

  • For professional dental use only.
  • The product is supplied non-sterile.
  • Single use only. Do not reuse.
  • The abrasive coating and strip edges can cut or abrade if mishandled; maintain firm control of the strip at all times and keep the working motion confined to the restoration surface to avoid contact with the patient's gingiva or oral mucosa.
  • Wear gloves and eye protection for the entire procedure, and use a face mask in line with the dental practice's standard precautions.
  • Do not use the product if the strip is damaged, contaminated, torn, or if the abrasive coating is peeling.
  • Do not use the product if its packaging is damaged.
  • Rinse the working area between abrasive steps to remove abrasive particles and debris.
  • Dispose of used strips immediately after use in accordance with local regulations and the dental facility's procedures.

Instructions for Use — Abrasive Strips (Coarse, Medium, Fine, Extrafine)

  1. Remove excess restorative material with a suitable rotary instrument before use.
  2. Select the strip with the abrasive grade appropriate for the required step.
  3. Take the strip out of its packaging immediately before use.
  4. Insert the strip between the interproximal contact points.
  5. Firmly hold both ends of the strip and move it back and forth over the restoration surface.
  6. Rinse the treated area with water to remove abrasive particles and debris.
  7. Repeat with the next finer grade if required.
  8. After use, discard the strip.

Using the Transparent Matrix Strip (Before Light-Curing)

  1. Before light-curing the composite restoration, take the Transparent Matrix strip out of its packaging.
  2. Insert the strip between the interproximal contact points and adapt it around the uncured restorative material to shape the interproximal contour.
  3. Hold the strip in position and light-cure the restoration according to the restorative material's instructions for use.
  4. Remove and discard the strip after curing is complete.

Storage, Transport and Shelf Life

Store the product in a clean, dry place, protected from direct sunlight, moisture, and excessive heat.

Transport the product in closed packaging and protect it from moisture, heat, and mechanical damage.

Shelf life: 18 months.

The expiry date, LOT number and REF are indicated on the product packaging.

Disposal

Used strips must be disposed of in accordance with local regulations and the dental facility's procedures for used dental materials.

Package Contents

SS01E — Seika Strip Coarse, 10 strips.

SS02E — Seika Strip Medium, 10 strips.

SS03E — Seika Strip Fine, 10 strips.

SS04E — Seika Strip Extrafine, 10 strips.

SS05E — Seika Strip Transparent Matrix, 10 strips.

SS14E — Seika Strip kit, 4 strips (one of each abrasive grade).

SS15E — Seika Strip assorted + Matrix, 5 strips (one of each abrasive grade plus one Transparent Matrix strip).

Reporting serious incidents

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established. Enquiries about a suspected serious incident can also be sent to support@kagayaki.eu.

Manufacturer and EU Authorised Representative

Manufacturer: Shenzhen Kagayaki Technology Co., Ltd., 301, Building 1, Zhenyu 2nd Road, Fifth Industrial Zone, Yulu Community, Yutang Subdistrict, Guangming District, Shenzhen, China. EUDAMED Single Registration Number (SRN): CN-MF-000050831.

EU Authorised Representative: Aleksandra Bashinskaia, Urbanização Crastos, Lote 43, 8400-450, Porches, Portugal. EUDAMED Single Registration Number (SRN): PT-AR-000050489. Phone: +351 926605123. Email: ra.pt@kagayakipolish.com.

For general enquiries or to submit a complaint, contact support@kagayaki.eu.

Document Information

  • Instructions for Use for Seika Strip Dental Finishing and Polishing Strips.

Explanation of Symbols

Consult instructions for use
Do not reuse
Caution
Medical device
CE marking
Temperature limit
Keep away from sunlight
Keep dry
Non-sterile
Manufacturer
Authorised representative in the European Union
Catalogue number
Batch code
Use-by date
Unique device identifier
Country of manufacture
ProductREFEAN / GTIN
Seika Strip Coarse, 10 pcsSS01E06978412680223
Seika Strip Medium, 10 pcsSS02E06978412680230
Seika Strip Fine, 10 pcsSS03E06978412680247
Seika Strip Extrafine, 10 pcsSS04E06978412680254
Seika Strip Transparent Matrix, 10 pcsSS05E06978412680261
Seika Strip kit, 4 pcs (one of each abrasive grade)SS14E06978412680278
Seika Strip assorted + Matrix, 5 pcs (four grades + Matrix)SS15E06978412680285

Revision 1 · Published  · Last updated 

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