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Flor-opal Sustained-release Fluoride Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Flor-Opal is designed for use whenever topical fluoride application is desired via take-home tray (e.g., prevention of root caries, treatment of periodontal conditions, following bleaching procedures, root sensitivity).
History
There is currently no drug history available for this drug.
Other Information
Flor-Opal® is a unique, sustained-release, 0.5% fluoride ion in a sticky, viscous gel to be used with a custom tray. Flor-Opal is a clear, nearly tasteless, high-viscosity sticky gel with a pH of ~6.5.
Sources
Flor-opal Sustained-release Fluoride Manufacturers
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Ultradent Products, Inc
Flor-opal Sustained-release Fluoride | Ultradent Products, Inc
1. Read and understand instructions before using or dispensing to patients. 2. Fabricate tray to meet patient's needs. See laboratory instructions (page 2) or send the working cast/model and prescription order form to Ultradent. Areas of sensitivity should be indicated on the cast before sending the model. If patient already has a custom bleaching tray, instruct them to apply Flor-Opal in the same manner as the bleaching gel.
Note: Trays made only for Flor-Opal may be constructed without scalloping; however, one should scallop trays made for Opalescence® bleaching. 3. Flor-Opal is dispensed in 1.2ml unit dose syringes. An application of a complete arch should use most of the contents of one unit dose syringe. Tray is loaded by running gel on underside of occlusal and incisal areas. 4. The length and number of times the tray is worn depends on the condition, the patient, and the clinician. Recommended treatment times generally range from 2 to 8 hours. Wearing the tray at night may be suggested since the gel generally stays active in the tray 8-10 hours because of slower muscle and salivary activity at night. Gel usually lasts 4-6 hours with daytime activity. 5. Tray should be removed at meal times. Following tray removal, patient should brush and rinse with water. DO NOT swallow solution during rinsing. Wash tray and store in a tray storage case. Fresh gel should be used for each application. 6. Gel may be warmed before placing in tray to avoid thermal sensitivity.Fig. 1
Fig. 2
1. Pour and trim cast as you would for a standard bleaching tray. Apply 0.5-1.0mm of Ultradent ® LC Block-Out Resin to a clean, dry cast. 2. Cure LC Block-Out for ~2 minutes in a light curing unit. A hand-held intraoral light (Ultra-Lume ®) can be used (approximately 20-40 seconds per tooth). Wipe off oxygen inhibition layer. 3. With vacuum former (Ultra-Form ® or EconoForm™), heat a Sof-Tray ® sheet until it sags ~1 inch. Activate vacuum and adapt softened plastic over mold. Cool and remove model. 4. Cut excess bulk of material away with Ultra-Trim™ scalloping scissors. 5. Trim excess tray material. Contour the tray margin to avoid frenum attachments, tori, and similar anatomical structures. 6. Return tray to model; check tray extensions. Gently flame polish edges one quadrant at a time (Blazer ® Micro Torch). 7. While still warm, hold periphery of each segment firmly against model for 3 seconds with watermoistened finger. If an area is short of the desired length, gently heat and push the tray material to the desired location. If this material thins too much, a new tray should be fabricated.
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