(77 days)
Not Found
No
The summary describes a standard dental air-powered handpiece with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a high-speed air turbine handpiece intended for mechanical dental procedures like removing carious material and preparing teeth, not for treating or preventing disease.
No
The device is described as being used for removing carious material, reducing tooth structure, cavity preparation, finishing, and polishing teeth. These are all interventional or restorative procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze disease or conditions.
No
The device description explicitly states it is a "Dental Air-Powered Handpiece," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a mechanical action on the tooth (removing material, preparing cavities, polishing). This is a direct intervention on the patient's body.
- Device Description: It's described as a "Dental Air-Powered Handpiece," which is a tool used for physical manipulation.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not involve the analysis of specimens.
The description clearly indicates a device used for direct dental procedures on a patient, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
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
tooth
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 comparisons of formulations and intended uses of the PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series 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.
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Glows
PENG LIM ENTERPRISE CO., LTD. 2F.NO.67 HWA RONG ROAD KU SHAN DIST., KAOHSIUNG TAIWAN. R.O.C. Tel:886-7-395-3080 886-7-5522995 Fax:886-7-3952830 886-7-5522023 E-mail:penglim(@ms9.hinet.net http://www.penglim.com.tw
K0629017
5. 510(K) SUMMARY
DEC 1 4 2006
PENG LIM High Speed Air Turbine Handpiece Models: Super-AIR and Super-QD series
510K:
| Submitted by: | PENG LIM ENTERPRISE CO., LTD. | ||
|---|---|---|---|
| 67 HWA RONG RD., 2F, KU SHAN DIST., | |||
| KAOHSIUNG, 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 24, 2006 | ||
| 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: | Dental Air-Powered Handpiece, | ||
| models: TIGER 100, TIGER 101, TIGER 200, | |||
| TIGER 201, TIGER 202 | |||
| 510K No -K052822 | |||
| Statement of Intended Use: | The PENG LIM High Speed Air Turbine | ||
| Handpieces are intended for removing carious | |||
| material, reducing hard tooth structure, cavity | |||
| preparation, finishing tooth preparations and |
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
tooth
preparations
and
restorations and polishing teeth.
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Glows
PENG LIM ENTERPRISE CO., LTD. 2F.NO.67 HWA RONG ROAD KU SHAN DIST., KAOHSIUNG TAIWAN, R.O.C. Tel:886-7-395-3080 886-7-5522995 Fax:886-7-3952830 886-7-5522023 E-mail:penglim@ms9.hinet.net http://www.penglim.com.tw
- Performance Data: ● The claim of substantial equivalence is based on comparisons of formulations and intended uses of the PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series and its claimed predicate.
- Conclusion: Based on the information in the notification, PENG . LIM Enterprise Co., Ltd. believes that High Speed Air Handpieces, models: Super-AIR and Turbine Super-QD series are substantially equivalent to the claimed predicate, i.e., Dental Air-Powered Handpiece, models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202, (K052822).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jen Ke Min Peng Lim Enterprise Company, Limited No. 58, Fu-Chiun Street Hsin-Chu City, 30067 Taiwan R.O.C
DEC 1 4 2006
Re: K062947
Trade/Device Name: PENG LIM High Speed Air Turbine Handpiece, Models: Super-AIR and Super-OD Series Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 23, 2006 Received: October 17, 2006
Dear Dr. Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Dr. Jen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing vour device as described in your Section 510(k) premarket notification. 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), please 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,
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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Glaws
PENG LIM ENTERPRISE CO., LTD. F.NO.67 HWA RONG ROAD U SHAN DIST., KAOHSIUNG AIWAN, R.O.C. el:886-7-395-3080 886-7-5522995 Fax:886-7-3952830 886-7-5522023 E-mail:penglim @ms9.hinet.net http://www.penglim.com.tw
Indications for Use
510 (K) Number ( If Known ): _________________________________________________________________________________________________________________________________________________
PENG LIM High Speed Air Turbine Handpiece, . Device Name:
Models: Super-AIR and Super-QD series
Indications for Use :
- PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
· PENG LIM High Speed Air Turbine Handpiece carries the following label:
CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
Prescription Use V
AND/OR
Over-The-Counter Use
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(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| ( | |
| ( | of Anesthesiology, General Hospital, |
| ( | Infection Control, Dental Devices |
| (510(k)) Number: | K062947 |
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