Predicta® Bioactive Desensitizer Gel

Product Description and Instructions for Use

Product Description

Predicta® Bioactive Desensitizer Gel is used for the treatment of dental hypersensitivity. It features next-generation chemistry, rendering the product highly biocompatible and bioactive. Predicta Bioactive Desensitizer releases calcium and phosphate ions, stimulating rapid hydroxyapatite crystal formation on the surface of treated dentin and within dentinal tubules. This results in a solid mineral layer atop treated dentin and solid mineral plugs that occlude dentinal tubules, providing robust pain relief for patients. This product is intended for use by a professional dental clinician.

Predicta Desensitizer is an easy-to-use gel, requiring no mixing prior to use. It is packaged in hand-dispensable syringes and applied using simple applicator brushes. It does not provide permanent tooth desensitization and may require re-application.

Indications

Predicta Bioactive Desensitizer Gel is indicated for the reduction of tooth hypersensitivity by the following treatments:

Treatment of dentin exposed by toothbrush abrasion, gingival recession, periodontal disease, and/or acid erosion.
Treatment of dentin after mechanical tooth cleaning, scaling, and/or root planing.
Treatment of tooth hypersensitivity associated with bleaching.
Treatment of prepared dentin for fillings and/or prosthetic restorations.

Contraindications

Patients with a history of sensitivity to this product or nano-hydroxyapatite-based products.

Basic Safety Instructions

Keep out of reach of children.
For dental use only.
Contact between Predicta Bioactive Desensitizer Gel and sensitive or inflamed soft tissues (mucosa, eyes, nose, etc.) may cause irritation, dermatitis, and/or inflammatory reactions. If this occurs, discontinue use, flush the area with copious amounts of water, and consult a physician.
Use a rubber dam or other suitable isolation method to prevent contamination of surfaces.
Prior application of some medicaments (desensitizers, varnishes, liners, etc.) or products with eugenol is not recommended, as they may reduce the efficacy of this product.
Avoid contamination of product. Do not return dispensed components to their original container. Dispose of leftover material properly. Do not reuse applicator brushes to avoid cross-contamination.
Please review the Safety Data Sheet (SDS) at www.parkell.com before use.

Clinical Procedure for Tooth Desensitization

Using appropriate diagnostic tests and professional clinical judgment, confirm that the patient’s cold sensitivity is related to exposed dentin from cervical root exposure. Rule out dental caries, tooth fracture, occlusal trauma, endodontic pathology, and any other possible dental or medical problems.
Explain to the patient what you’re proposing to do to treat their problem and obtain informed consent.
To reduce the plaque load, have the patient rinse their mouth with mouthwash diluted with warm water. Remove any plaque or debris from the tooth surface with gentle hand instrumentation. Avoid excessive force or rotary polishing, which may make the pain worse. Rinse the root surface with warm water and gently dry with absorbent cotton to avoid cold sensitivity from compressed air or vacuum suction. Use local anesthesia only if necessary, as it will make post-op testing impossible at this visit.
Isolate the sensitive tooth to be treated with appropriate lip and tongue retraction devices.
Remove the cap from the Predicta Bioactive Desensitizer gel syringe and set it aside. Affix a tip to the syringe and extrude a small amount into the plastic mixing well.
Saturate a cotton pledget or precision applicator with the material and massage it into the tooth for 30-40 seconds. The patient may feel a slight “rush”, but it shouldn’t hurt. Using a rubbing motion will liquefy the gel and allow it to penetrate the surface. If the applicator dries out, re-wet it with more gel.
Wipe most of the gel off with a cotton roll and gently test the tooth by having the patient rinse with cool tap water. Repeat the procedure (if necessary), until the cold sensitivity is gone.
If the patient has not been anesthetized, and the tooth is still sensitive, repeat the application of Predicta Bioactive Desensitizer gel. If sensitivity persists after a second application, consider other possible sources for the pain (e.g., high occlusion, pulpal pathology, extreme root erosion, etc.). If the patient has been anesthetized, test at the next visit.
Issue appropriate post-op instructions and dismiss the patient.
Discard the applicator tip and seal the syringe with the original product cap.
Disinfect the syringe as per the disinfection instructions below.

Tips for Dental Practitioners

To reduce the risk of cross-contamination between patients when using multiple-use dental dispensers:

Apply disposable barrier sleeves/wraps over multiple-use dental dispensers before use with each patient.
Use new, uncontaminated gloves when handling multiple-use dental dispensers.
Utilize dental assistants to dispense material for the dentist.
Avoid contact of the reusable parts (e.g., the body of the multiple-use dental dispenser) with the patient’s mouth.
Do not reuse the multiple-use dental dispenser if it becomes contaminated.
Do not reprocess a contaminated multiple-use dental dispenser by using chemical wipes or disinfectants.
Do not immerse multiple-use dental dispensers in a high-level chemical disinfectant, as this may damage the dispenser and the material contained in the device.
Do not sterilize multiple-use dental dispensers, as this may damage the material contained in the device.

Storage and Shelf Life

Store in a dry place at 2–25 °C (36–77 °F). Store tightly sealed, away from direct light. Do not freeze, it may affect the clinical performance of the product. Use at room temperature. Do not store near eugenol-containing materials. Do not use after the expiration date.

Disposal of Material

The material can be disposed of in general refuse. All cartridges and needle tips may be disposed of in normal refuse.

Events

Reportable incidences should be reported to Parkell and the competent authority in which the user and/or patient is established.

Warranty

For full Warranty and Terms of Use information, please visit our website at www.parkell.com. Parkell’s Quality System is certified to ISO 13485.

Explanation of Symbols Used

Professional use only: Indicates the product is intended for use by licensed dental professionals.
Follow instructions for use: Advises users to adhere to the provided instructions.
Temperature limit: Specifies the recommended storage temperature range (2–25 °C).
Keep away from sunlight: Advises protection from direct light during storage.
Use-by date (expiration): Indicates the product's expiration date.
Batch code: A code identifying the production batch.
Catalogue / stock number: Identifies the product in the catalog.
Unique Device Identifier (UDI): A unique identifier for the medical device.
Medical Device: Symbol indicating it is a medical device.
Package contents: Refers to the items included in the package (e.g., Syringe, Applicator Brushes, Mixing Dish).
Do not use if package is damaged: Safety instruction regarding damaged packaging.
Manufacturer: Indicates the manufacturer of the product.
Single use only: For applicator tips and possibly other components.
Dispensing Tips: Refers to the tips used for dispensing the gel.
Mixing Dish: A dish for mixing materials if required (though this product does not require mixing).

Contact Information

Manufacturer: Parkell

Address: 300 Executive Dr., Edgewood, NY 11717 USA

Phone: (800) 243-7446

Website: www.parkell.com

Translation Services: mt-g medical translation GmbH & Co KG, Stuttgarter Straße 155 • D-89Models: S625, Predicta Bioactive Desensitizer, Bioactive Desensitizer, Predicta Desensitizer, Desensitizer

File Info : application/pdf, 2 Pages, 1.67MB

Predicta-Desensitizer-ifu

References

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