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The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy.

Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Endodontology /

Removal of diseased or inflamed soft tissue in the periodontal - Periodontology / pocket ( sulcular debridement )

• Soft Tissue

Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis

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This document is a 510(k) clearance letter from the FDA for a medical device called the "DENTEK LD 15 Diode Laser". It states that the device is substantially equivalent to a predicate device, allowing it to be marketed.

However, the provided text does not contain any information regarding specific acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, ground truth types, or details about the training set used for evaluating the device.

The document primarily focuses on the regulatory clearance for the device and its stated indications for use. Therefore, I cannot generate the requested table and study details from the provided text.

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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.

Ask a specific question about this device