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Cutting, shaving, contouring and resection of oral osseous tissues (bone)

Not Found

This submission for the DELight Dental Laser System (K032797) contains no information on acceptance criteria or a study proving device performance against such criteria.

The 510(k) Summary explicitly states:

• "Nonclinical Performance Data: None"
• "Clinical Performance Data: None"

Therefore, I cannot provide the requested information. The device was cleared based on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without new performance data being submitted or reviewed.

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• Tooth preparation to obtain access to the root canal
• Pulpotomy
• Pulp extirpation
• Pulpotomy as an adjunct to root canal therapy
• Root canal debridement and cleaning
• Root canal preparation including enlargement

Not Found

The provided 510(k) summary for the DELight dental laser system does not contain information related to acceptance criteria or a study proving the device meets such criteria.

The summary explicitly states:

• Nonclinical Performance Data: None
• Clinical Performance Data: None

This submission relies on substantial equivalence to predicate devices (WaterLase, Millennium dental laser system) without presenting new performance data. Therefore, I cannot fulfill the request to provide the table of acceptance criteria, reported device performance, or details about any study, as no such information is present in the provided text.

Ask a specific question about this device