(108 days)
Not Found
No
The 510(k) summary describes a standard air-powered dental handpiece and does not mention any AI or ML components or functionalities.
Yes
The device is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations, and polishing teeth, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" section describes the device's function as removing carious material, reducing tooth structure, preparing cavities, finishing tooth preparations and restorations, and polishing teeth. These are all active treatment procedures, not diagnostic functions.
No
The device description clearly identifies the device as a "Dental Air-Powered Handpiece," which is a physical hardware device used in dentistry. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for mechanical procedures on teeth (removing material, preparing cavities, finishing, polishing). This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description "Dental Air-Powered Handpiece" aligns with a tool used for physical manipulation of teeth, not for analyzing biological samples.
- Anatomical Site: The anatomical site is "hard tooth structure, teeth," which are parts of the body being directly worked on.
The information provided strongly indicates this is a dental tool used for direct treatment, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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-Min
No.58, Fu-Chiun Street, Hsin-Chu City, Taiwan, ROC
Tel: 886-3-5208829 fax: 886-3-5209783
E-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: EFB
Panel: 72 |
| Predicate Device: | CODENT Dental Air-Powered Handpiece,
model: HPS
510K 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. |
1
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)
2
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.
3
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