nemoci-sympt/ZUBNI/laserove-cisteni-zubu/druhy-pouziti-laseru
Druhy zubních laserů
- Sulcular Debridement (sometimes termed Laser Curettage)
- Laser-Assisted New Attachment Procedure (LANAP)
- Reduction of Bacteria Levels in periodontal pockets (sometimes termed Pocket Sterilization)
- Laser-facilitated Wound Healing
- Laser Root Planing
- Aid in the Diagnosis of Caries (Laser Fluorescence)
- Hard Tissue Applications
- Including endodontics [1]
Varování stran bezpečnosti
- The Council encourages dental practitioners to cautiously consider claims of safety and efficacy that are purely based on the product having been cleared for market by the FDA through the 510(k) process.
- It is appropriate and prudent for the practitioner to request detailed information from the manufacturer about the scientific evidence that forms the basis for the marketed use.
- This information will help the dentist to discuss the benefits and risks of the treatment options with patients. [1]
- Dental lasers obtaining 510(k) clearance may be labeled, promoted, and advertised by the manufacturer for only those specific indications for use for which the devices have been cleared for marketing.
- Dental laser manufacturers must seek FDA 510(k) clearance for each laser product and each specific indication for use.
- Not every laser is cleared for every conceivable use.
- Therefore, FDA marketing clearances apply to certain products that are specific to the manufacturer and product.
- For any specific laser device, the specific indications for use, as marketing clearances, can be found in the professional information section of the operator’s manual for the device. [1]
- Additional uses for dental lasers are considered “off label use.”
- Within the scope of a license to practice, dentists may choose to use lasers or other products “off label.”
- Practitioners should consider off label use in light of possible benefits and risks, patient needs, and the available scientific evidence.
- The Council recommends that dentists read and understand the specific indications for use for each device.
- Practitioners may:
- The FDA Web site www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
- Call the FDA
- Consult with the manufacturer for specific and up-to-date information about cleared indications for use [1]