DSI DENTAL DS-SG1020 Sponge Graft Grafting Dental Solution Instruction Manual

June 2, 2024
DSI DENTAL

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DSI DENTAL DS-SG1020 Sponge Graft Grafting Dental Solution

DSI-DENTAL-DS-SG1020 Sponge-Graft-Grafting-Dental-Solution-
PRODUCT

Product Information

Specifications

  • Product Name: DSI Sponge Graft
  • Application: One-step Bone Grafting Dental Solution for Socket preservation
  • Reference: DS-SG1020
  • Packaging: Double sterile envelope or blister tray for single use only
  • Sterilization Method: Irradiation
  • Manufacturer:www.dsisrael.com

Usage Instructions

  • CAUTION: Clinicians should have expertise in periodontal therapy, bone augmentation, and implant procedures.
  • Improper technique may lead to compromised results.
  • Do not exceed the indicated applications to avoid complications.
  • PACKAGING: Each box contains a product in a double sterile envelope or blister tray.
  • The product is for single use only.
  • Do not use it if the packaging is damaged, torn, or appears opened.

Symbols

  • Consult instructions for use
  • Caution, consult accompanying documents
  • Temperature limit
  • Keep away from sunlight
  • Keep dry
  • Do not reuse
  • Do not use it if the package is damaged
  • Do not resterilize
  • Sterilized using irradiation
  • Medical Device Use by Prescription only
  • Manufacturer Catalogue number
  • Batch code
  • Use by Date of Manufacture
  • Note: Failure to comply with storage conditions can alter material characteristics and reduce shelf life.
  • The manufacturer disclaims responsibility for quality loss due to non-compliance with transportation, storage, and usage terms.

Frequently Asked Questions (FAQ)

Can the DSI Sponge Graft be reused?

No, the product is intended for single use only. Do not reuse to prevent complications.

How should I store the DSI Sponge Graft?

Store the product away from sunlight, keep it dry, and ensure the packaging is intact until use to maintain product integrity.

What sterilization method is used for the DSI Sponge Graft?

The DSI Sponge Graft is sterilized using irradiation to ensure its safety for use in dental procedures.

INSTRUCTIONS FOR USE

  • DESCRIPTION: DSI Sponge Graft is a porous preformed bone grafting material.
  • It is comprised of highly purified type I bovine Achilles tendon collagen, combined with Syntoss bioactive resorbable graft.
  • Together, it simulate the natural collagen matrix and porous mineral structure of human bone.
  • Syntoss graft will show as radiolucent on the day of placement in a defect site by dental x-ray.
  • 4-6 months later, the defect site will be radiopaque. The exact timing depends on vascularity, patient’s age, and quantity of product delivered.
  • DSI collagen sponge with incorporated graft designed to prevent the migration of bone graft particles and connective tissue.

INDICATIONS OF USE

  • Periodontal and general maxillofacial surgery procedures.
  • Placed in extraction sockets before the insertion of dental implants.
  • Repair of intra-bony defects and ridge preservation.
  • Sinus Augmentation.
  • Wound healing post-dental implant surgery.
  • Guided Bone Regeneration (GBR) procedures.

INSTRUCTIONS FOR USE

Post-extraction socket preservation:

  1. Curettage, debridement, and enucleation are performed to remove pathogens. Basic surgical techniques are necessarily the surgeon’s responsibility.
  2. Sponge Graft Plug is designed specifically for socket preservation following tooth extraction. Remove with sterile forceps from the packaging, cut, if necessary, and deliver into the socket.
  3. Press to conform to the site. Place the remaining pieces, if any, over the socket.
  4. Gauze can be used to compact the product and remove excess blood. Cross-suture the tissue over tooth extractions.

For sinus lifting:

  1. Cut and soak several Sponge Graft Plugs with the patient’s blood or sterile saline.
  2. Fill the sinus cavity and place it up against the new designated sinus floor.
  3. Cut the plug in two, cover the surgical sinus window, and suture.
  • For large buccal cortical defects, ridge augmentations, and onlay grafting:
  • The cortical bone is decorticated and perforated to accelerate blood and cell delivery from the endosteum.
  • Avoid major landmarks during perforation (e.g., neighboring roots, mandibular canal, sinus, trigeminal nerves, mental foramen, etc.). Cut and deliver the Sponge Graft plug dry for better control and adaptability.
  • Cover the site if necessary and suture. Screws or bone tacks can be used to secure the larger parts.

Post-op:

  • Ice bags after surgery are recommended. Basic oral hygiene with warm salt water and rinse twice daily. No topical tooth brushing at the wound site. Refrain from the use of water systems.
  • CAUTION: Clinicians should be familiar with periodontal therapy, bone augmentation, and implant procedures.
  • Improper technique may result in compromised results. Do not use beyond indicated applications.
  • CONTRAINDICATIONS : The product contains bovine collagen material and may be contraindicated in patients with a history of allergic reactions to bovine collagen-derived products.

Do not use with:

  • Patients with acute infection in surgical site or oral wound cavity with existing acute or chronic infection, as well as any systemic or autoimmune disease or complications.
  • In surgical sites with inflammatory bone diseases such as osteomyelitis.
  • In the presence of metabolic or systemic bone disorder.
  • Children and pregnant women.
  • In a wound complications may occur, including, but not limited to hematoma, edema, swelling and fluid accumulation, tissue thinning, infection, or other complications that are possible with any surgery.
  • STORAGE: The product should be stored in a dry place with controlled room temperature conditions below 25°C (77°F). Do not freeze or expose to direct sunlight.
  • PACKAGING: Each box contains a product in a double sterile envelope or blister tray.
  • The product is intended for single use only. Do not use it if the packaging is damaged, torn, or appears opened.
  • REF: DS-SG1020

SYMBOLS

  • Consult instructions for use
  • Caution, consult accompanying documents
  • Temperature limit
  • Keep away from sunlight
  • Keep dry
  • Do not reuse
  • Do not use it if the package is damaged
  • Do not resterilize
  • Sterilized using irradiation
  • Medical Device
  • Use by Prescription only
  • Manufacturer
  • Catalog number
  • Batch code
  • Use by
  • Date of Manufacture
  • Failure to comply with the conditions of storage leads to a change in the working characteristics of the material and decreases the shelf life of the material.
  • The manufacturer is not responsible for any loss of quality caused by the failure to comply with the terms of transportation, storage, and use established by the manufacturer for this product.
  • Responsibility for the use of the material for purposes other than those specified by the manufacturer falls on the user.
  • www.dsisrael.com

Documents / Resources

| DSI DENTAL DS-SG1020 Sponge Graft Grafting Dental Solution [pdf] Instruction Manual
DS-SG1020 Sponge Graft Grafting Dental Solution, DS-SG1020, Sponge Graft Grafting Dental Solution, Graft Grafting Dental Solution, Grafting Dental Solution, Dental Solution
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