(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.
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Image /page/0/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it on the left. To the right of the circle, the words "Thunder Tiger" are written in a bold, stylized font, with "Thunder" on top of "Tiger".
THI NDER TIGER CORP. No 7, 64 Road, industry park. Taching Tancan ROR' 407 Tel. 886-4-23591616 - Fax. 886-4-23591092 http://www.thunderinger.com E-mail the thundertiges com
JAN
5. 510(K) SUMMARY
CONDENT Dental Air-Powered Handpiece Models: HPS
510K:
| Submitted by: | THUNGER TIGER CORP.No.7, 6th Road, Industry Park, Taichung, 407,Taiwan, ROC |
|---|---|
| Contact person: | Dr. Jen, Ke-MinNo.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, ROCTel: 886-3-5208829 fax: 886-3-5209783E-mail: ceirs.jen@msa.hinet.net |
| Date Summary Prepared: | September 23, 2005 |
| Name of the Device: | Dental Air-Powered Handpiece |
| Classification: | Dental Air-Powered Handpiece ( class I medical device; 21 CFR 872.4200 )Product code: EFBPanel: 72 |
| Predicate Device: | CODENT Dental Air-Powered Handpiece,model: HPS510K No - K033213 |
| Statement of Intended Use: | The THUNDER TIGER Dental Air-Powered Handpiece is 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. |
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Image /page/1/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane in the middle on the left side. To the right of the circle, the words "Thunder Tiger" are written in a stylized font, with "Thunder" on top and "Tiger" on the bottom.
NDER TIGER CORP. 2 Road milusiry park 2 Tarvan, ROK 407 cl. 886-4-23591616 - Fax. 886-4-23591092 Formad 11 millingerifger com hip www.thouderinger.com
The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the THUNDER TIGER Dental Air-Powered Handpiece and its claimed predicate. Conclusion:
Based on the information in the notification THUNDER TIGER believes that Dental Air-Powered Handpiece HPS is substantially equivalent to the claimed predicate, i.c., CODENT Dental Air-Powered Handpiece, (K033213)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
JAN 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thunder Tiger Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society 58 Fu-Chiun Street Hsin Chu City, Taiwan 300
Re: K052822
Trade/Device Name: Dental Air-Powered Handpiece, Models TIGER 100, TIGER101, TIGER 200, TIGER 201, TIGER 202 Regulation Number: 872.4200 Regulation Name: Dental Handpicce and Accessories Regulatory Class: 1 Product Code: EFB Dated: December 20, 2005 Received: December 28, 2005
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to review your end have determined the device is substantially equivalent (for the referented a o re as a ted in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to act rood Cosmetic Act (Act) that do not require approval of a premarket the Federal PUCA). You may, therefore, market the device, subject to the general appeared with of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wrl), it hay be budyout is and Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Dr. Chai
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements moun that I Dr. mas Federal statutes and regulations administered by other Federal agencies. or the For any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (2) es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as better in product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins feter wiffication. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rr you contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Qure
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Thunder Tiger. The logo consists of a circle with an airplane inside of it, followed by the words "Thunder Tiger" stacked on top of each other. The text is in a bold, sans-serif font.
Fax 886-1-2350 High 11 22 1 3 1 3 6 6 2 2 2 2 2 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Ing inwas thouderinger com
Indications for Use
510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________
. Device Namc: Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
Indications for Use :
- . 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.
- · THUNDER TIGER Dental Air-Powered Handpiece carries the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRII, Office of Device Evaluation (ODE)
Page 1 of 1
K052872
Ps
§ 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.