(76 days)
Not Found
No
The summary describes a standard dental handpiece and makes no mention of AI, ML, or related technologies.
No
This device is a dental handpiece used for procedures like removing carious material and preparing teeth, which falls under surgical or procedural tools rather than devices for therapy. It's intended for mechanical alteration rather than healing or treating disease.
No
The device description indicates it is a dental handpiece used for removing carious material, reducing hard tooth structure, cavity preparation, finishing, and polishing teeth, which are all treatment-oriented functions rather than diagnostic ones.
No
The device description and intended use clearly describe a physical dental handpiece, which is a hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for physical 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the ROLENCE Dental High Speed Handpiece is a dental surgical/procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ROLENCE Dental High Speed Handpiece, model RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
CAUTION: U.S. Federal law restricts the use of this device to licensed professionals.
Product codes
EFB
Device Description
According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.
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 . comparisons of formulations and intended uses of the ROLENCE Dental High Speed Handpiece, model RHP and its claimed predicate.
And we also refer to the ISO7785-1 to verify the function test for the ROLENCE Dental High Speed Handpiece.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997
5. 510(K) SUMMARY
DEC 1 6 2009
ROLENCE Dental High Speed Handpiece, Model: RHP
| 510K: | |
|---|---|
| Submitted by: | ROLENCE Enterprise Inc. |
| No.18-3, Lane 231, Pu Chung Rd., Chungli, 32083, | |
| Taiwan, ROC | |
| Contact person: | Dr. Jen, Ke-Min |
| No.58, Fu-Chiun Street, Hsin-Chu City, 30067, | |
| Taiwan, ROC | |
| Tel: 886-3-5208829 fax: 886-3-5209783 | |
| E-mail: ceirs.jen@msa.hinet.net | |
| Date Summary Prepared: | September 18, 2009 |
| 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 | |
| Proprietary name: | ROLENCE Dental High Speed Handpiece, model RHP |
| Predicate Device: | JINDELL High Speed Air Turbine Handpiece, |
| models: SW, SP, SU, ETU, MU; 510K No – K062740 | |
| Statement of Intended Use: | The ROLENCE Dental High Speed Handpiece, |
| model RHP is intended for removing carious | |
| material, reducing hard tooth structure, cavity | |
| preparation, finishing tooth preparations and | |
| restorations and polishing teeth. | |
| CAUTION: U.S. Federal law restricts the use of | |
| this device to licensed professionals. |
P6
1
Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997
- Description of Device Design: According to ISO7785-1:1997, Dental Handpiece . -- Part 1: High-speed air turbine handpieces; and ISO13485:2003, Medical Device Quality Management System to complete the device design steps.
- Risks Analysis Method: According to ISO14971:2007, we completed the Risks ● Management Report for the ROLENCE Dental High Speed Handpiece.
- Performance Data: The claim of substantial equivalence is based on . comparisons of formulations and intended uses of the ROLENCE Dental High Speed Handpiece, model RHP and its claimed predicate.
And we also refer to the ISO7785-1 to verify the function test for the ROLENCE Dental High Speed Handpiece.
- Conclusion: Based on the information in the notification, ROLENCE . Enterprise Inc. believes that the Dental High Speed Handpiece is substantially equivalent to the claimed predicate JINDELL High Speed Air Turbine Handpiece, models: SW, SP, SU, ETU, MU, 510K No. K062740.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
DEC 1 6 2009 ROLENCE Enterprise Incorporated C/O Mr. Shu-Chen Cheng ROC Chinese-European Industry Research Society 2064 Tamarin Drive Columbus, Ohio 43235
Re: K093084
Trade/Device Name: Rolence Dental High Speed Handpiece Model RHP Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 20, 2009 Received: October 1, 2009
Dear Mr. Cheng:
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 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.
3
Page 2- Mr. Cheng
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/SafetyReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
. for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Rolence Enterprise Inc. 18-3 Lane 231 PuChung Rd. ChungLi 320 Taiwan R.O.C. Tel: +886-3-463 1999 ext 10 Fax: +886-3-463 1997
Indications for Use
510 (K) Number ( If Known ): _ K (J 9 3084
ROLENCE Dental High Speed Handpiece, Model: RHP ● Device Name:
Indications for Use :
- · ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
• ROLENCE Dental High Speed Handpiece carries the following label:
CAUTION: U.S. Federal 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 CDRH, Office of Device Evaluation (ODE)
Kevin Muly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093084
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