(108 days)
THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
This submission refers to a 510(k) premarket notification for a Dental Air-Powered Handpiece (Models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202) by THUNDER TIGER CORP. The device's substantial equivalence is based on performance data comparing it to a predicate device, the CODENT Dental Air-Powered Handpiece (K033213).
However, the provided document does not contain the specific details required to describe acceptance criteria, the study proving the device meets those criteria, or most of the requested information (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance results).
The document primarily focuses on:
- The 510(k) summary, identifying the applicant, device name, classification, predicate device, and intended use.
- A statement of substantial equivalence based on performance data comparison.
- The FDA's decision letter confirming substantial equivalence.
- The Indications for Use statement for the device.
Based on the provided text, I can only provide the following limited information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Performance similar to predicate device (CODENT Dental Air-Powered Handpiece, K033213) | Based on performance data comparison, THUNDER TIGER believes its device is "substantially equivalent" to the predicate. No specific performance metrics or thresholds are provided in this document. |
| Intended Use as a Dental Air-Powered Handpiece for specific dental procedures | The device is intended for "removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth," which matches the typical intended use for such devices. |
The remaining requested information (2-9) cannot be extracted from the provided text as it is not present in the 510(k) summary or FDA letter. This type of detailed study information is usually found in the full 510(k) submission, which is not included here. Substantial equivalence claims for Class I devices like this often rely on design, material, and operational similarity to a predicate device, with internal testing to ensure basic functionality and safety rather than extensive clinical efficacy studies.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.