premier 9007560 Impregnated Knitted Cord Instruction Manual
- June 1, 2024
- Premier
Table of Contents
premier 9007560 Impregnated Knitted Cord
Product Specifications
- Contents : 100 inches (254 cm) Aluminum Chloride impregnated cord each in self-cutting container.
- Materials : NP Conjugated dyed Yarn (Nylon-6, PET) Impregnated with Aluminum Chloride.
- Item Numbers : 9007560, 9007561, 9007562, 9007563, 9007564, 9007565
Product Usage Instructions
- Intended Use :
Knit-Pak+ is a prescription-only, Aluminum Chloride Hexahydrate impregnated cord used for temporary chemo-mechanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth. It is intended for accurate and enhanced results when acquiring dental impressions, for cavity preparation, or wherever hemostasis and retraction is required.
Device Description:
The product includes Aluminum Chloride impregnated cords in self-cutting
containers. The cords are made of NP Conjugated dyed Yarn (Nylon-6, PET)
Impregnated with Aluminum Chloride.
Directions for Use :
- Evaluate the health of the gingiva and the depth of the sulcus.
- Select the impregnated cord of appropriate size and cut the cord.
Storage :
Close the cap after use and store in a dry place to maintain product
integrity.
Shelf Life:
The product has a specified shelf life; please check the expiry date before
use.
For Further Information:
To obtain Safety Data Sheets (SDS) or Instructions for Use (IFU), visit
premierdentalco.com or contact Premier at
610-239-6000.
FAQ
-
What is Knit-Pak+ used for?
Knit-Pak+ is used for temporary chemo-mechanical retraction of gingival tissues and hemostasis of the gingival margin around the tooth to enhance dental impressions and assist in cavity preparation. -
How should Knit-Pak+ be stored?
Knit-Pak+ should be stored in a dry place with the cap closed after each use to prevent contamination or moisture exposure. -
Are there any contraindications for using Knit-Pak+?
Individuals with known allergies to Aluminum chloride may experience adverse reactions such as irritation and pain when using Knit-Pak+. It is important to consider contraindications before use.
Knit-Pak™+
Impregnated Knitted Cord
UK Responsible Person:
MDSS-UK RP Ltd. 6 Wilmslow Road, Rusholme, Manchester M14 5TP, United Kingdom
- Premier® Dental Products Company 1710 Romano Drive
- Plymouth Meeting, PA 19462 USA 888-670-6100
- 610-239-6000 premierdentalco.com
- Made in Korea
IFU# 97560 1123059 Rev8 PDF
Intended Use:
Knit-Pak+ is a prescription-only, Aluminum Chloride Hexahydrate impregnated
cord is used for temporary chemo-mechanical retraction of gingival tissues and
hemostasis of the gingival margin around the tooth. It is intended for
accurate and enhanced results when acquiring dental impressions, for cavity
preparation or wherever hemostasis and retraction is required.
Device Description:
Premier® Knit-Pak+ is an aluminum chloride impregnated gingival retraction
cord created from knitted microfibers for temporary chemo-mechanical
retraction of gingival tissues and hemostasis of the gingival margin around
the tooth.
Contents:
100 inches (254 cm) Aluminum Chloride impregnated cord each in self-cutting
container.
Contraindications:
Knit-Pak+ is impregnated with aluminum chloride. Do not use on persons:
- With known allergy to aluminum chloride.
- With cases of acute gingivitis or acute necrotizing ulcerative gingivitis.
- With an intraoral site that has active infection or inflammation.
- With significant periodontal disease or furcation involvement.
PRECAUTIONS:
- Be sure to rinse treated area before taking impression to avoid inhibition of polymerization of impression material.
- The reuse of a single-use device can expose patients and staff to cross-contamination.
- Federal law restricts this device to sale by or on the order of a dentist.
WARNINGS:
- Do not apply excessive force and violate the biological width when packing the retraction cord into sulcus.
- Do not leave the cord in the gum for more than 20 minutes as this may cause a lasting recession of the gum.
- Ensure all aluminum chloride is removed by rinsing prior to dental impression to avoid inhibition of polymerization of impression material.
- Do not reuse cord. Cords are single-use only.
- Do not use in patients with known allergies to Aluminum Chloride.
- Aluminum Chloride is irritating to skin and eyes.
Adverse Reactions:
Adverse reactions may include but are not limited to:
- Recession of the gums from prolonged use or excessive force in sulcus.
- Additional procedures may be necessary if impression material was inhibited due to residual Aluminum chloride.
- Allergic type of reactions such as swelling, inflammation, irritation, and pain could occur in persons with known allergy to Aluminum chloride.
- If a serious incident has occurred in relation to the device, please report the incident to the Manufacturer and/or competent authority of the Member State where the device was used.
Materials :
NP Conjugated dyed Yarn (Nylon-6, PET) Impregnated with Aluminum Chloride.
| Item no. | Product Specifications |
|---|---|
| Body/Round container | PE (Polyethylene) |
| Cap | PE (Polyethylene) |
| Cutter | Ceramic Cutter |
Directions for Use
- Evaluate the health of the gingiva and the depth of the sulcus.
- Select the impregnated cord of appropriate-size and cut the cord to required length by closing the cap (ceramic blade in cap will sever the cord).
- Apply the cord tightly to the cervix of the tooth and carefully insert into sulcus by means of a cord packer hand instrument.
- Leave the cord(s) in the place and wait one (1) to three (3) minutes to displace the sulcus and stop any bleeding caused by preparation (do not exceed 20 minutes).
- Before removing the cord, it should be wetted/rinsed with water so it won’t grab and tear gingival tissue when removed creating more bleeding.
- Remove cord; rinse the area with a firm air/water spray to complete removal of Aluminum Chloride and dry preparation.
- Examine the treatment site to verify hemostasis.
- If the bleeding is persistent when the cord is removed, repeat the procedure from step 2 to step 7 until hemostasis is achieved.
Storage:
Close the cap after use and store in a dry place.
Shelf Life:
- Knit-Pak+ has a shelf life of 3 years (36 months) from the date of manufacturing.
- Do not use after device has expired. See expiry date on the device label.
For Further Information:
- To obtain SDS or IFU, visit premierdentalco.com or call Premier at 610-239-6000.
- A full explanation of symbols used on Premier® Dental packaging and literature is located at premierdentalco.com/symbol-glossary
- European Union authorized representative
- Swiss Union authorized representative
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>