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Intended Uses: The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue
Indications for Use:

• Soft Tissue
  . gingivectomy
  . gingival incisions and excisions
  . tissue retraction for impressions
  frenectomy
  . treatment of aphthous ulcers
  . excisional and incisional biopsies
  . incising and draining of abscesses
  . exposure of unerupted teeth
  . hemostasis

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental laser system (DENTEK LD-15 Diode Laser System). This document does not include acceptance criteria, performance data, or details of a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared because it was found to be "substantially equivalent" to a predicate device, not through a study demonstrating it met specific, independent acceptance criteria or performance metrics described in this document.

Therefore, I cannot extract the requested information (1-9) from the provided text as it is not present.

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