9007560 Knit-PakTM+ Knitted Retraction Cord Instruction Manual

9007560 Knit-PakTM+ Knitted Retraction Cord

Product Information

The Knit-PakTM+ is a prescription-only, Aluminum Chloride The 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 are required.

The product comes in a self-cutting container and contains 100 inches (254 cm) of Aluminum Chloride impregnated cord.

Materials: NP Conjugated dyed Yarn (Nylon-6, PET) Impregnated with Aluminum Chloride.

Product Usage Instructions

1. Evaluate the health of the gingiva and the depth of the sulcus.
2. Select the impregnated cord of the appropriate size.
3. Cut the cord according to the required length.
4. Follow the procedure from step 2 to step 7 to achieve hemostasis.

Storage:

After use, close the cap tightly and store the product in a dry place.

Shelf Life:

The shelf life of the product is not specified in the user manual. Please refer to the packaging or contact the manufacturer for information regarding the shelf life.

For Further Information:

To obtain Safety Data Sheets (SDS) or Instructions for Use (IFU), please visit premierdentalco.com or call Premier at 610-239-6000.

Symbols:

• Expiry date
• Manufacturer
• KR (European Union authorized representative)
• CH REP (Swiss Union authorized representative)
• Batch number
• Catalog Number
• Irritant
• Date and Country of Manufacture
• Do Not Reuse
• Caution: See instructions for use
• CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician
• Medical Device

Important Notes:

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.

INSTRUCTIONS FOR USE

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 the self- cutting container.

Specification

9007560

| •    Color – Dark Green

•    Size – 000.0

•    AlCl3 Content (wt.) – 0.5 ± 0.3 mg/ inch

9007561

| •    Color – Green

•    Size – 000

•    AlCl3 Content (wt.) – 0.5 ± 0.3 mg/ inch

9007562

| •    Color – Brown

•    Size – 00

•    AlCl3 Content (wt.) – 0.5 ± 0.3 mg/ inch

9007563

| •    Color – Purple

•    Size – 0

•    AlCl3 Content (wt.) – 0.5 ± 0.3 mg/ inch

9007564

| •    Color – Blue

•    Size – 1

•    AlCl3 Content (wt.) – 1.0 ± 0.4 mg/ inch

9007565

| •    Color – Orange

•    Size – 2

•    AlCl3 Content (wt.) – 1.0 ± 0.4 mg/ inch

Contraindications:

• Knit-Pak+ is impregnated with aluminum chloride. Do not use on persons:
• With a 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 the impression to avoid inhibition of the 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 the 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 the 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 the 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 allergies 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.

Directions for Use:

1. Evaluate the health of the gingiva and the depth of the sulcus.
2. Select the impregnated cord of the appropriate size and cut the cord to the required length by closing the cap (the ceramic blade in cap will sever the cord).
3. Apply the cord tightly to the cervix of the tooth and carefully insert it into the sulcus by means of a cord packer hand instrument.
4. Leave the cord(s) in 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).
5. 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.
6. Remove the cord; rinse the area with a firm air/water spray to complete removal of Aluminum Chloride and dry preparation.
7. Examine the treatment site to verify hemostasis.
8. 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 it after a device has expired. See the 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.

Expiry date

|  | Manufacturer
|  |

|  | Catalog Number
|  | Irritant
|  | Date and Country of Manufacture
|  | Do Not Reuse
| |
|  |
|  |

Medical Device

|  |

See IFU on premierdentalco.com

 |  |

See IFU on premierdentalco.com

 |  | Caution: See instructions for use
 |  | CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician
 |  | Medical Device
 |  |

See IFU on premierdentalco.com

 |  |
 |  | European Union authorized

representative

|  | GmbH Schiffgraben 41 30175 Hannover, Germany
European Union authorized representative
 |  |
|  | Swiss Union authorized representative

AarauSwitzerlandREPCH
Swiss Union authorized representative

• Premier® Dental Products Company
• 1710 Romano Drive, Plymouth Meeting, PA 19462 USA
• -670-6100 • 610-239-6000 • premierdentalco.com
• Made in Korea

References

• Premier Dental | PDC Home

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