(227 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical aspects of a dental handpiece, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
This device is a dental handpiece used for restoration procedures, which are generally considered a type of surgical intervention, not a therapeutic treatment in the sense of curing a disease or alleviating symptoms through non-surgical means. It facilitates the procedure but does not directly provide therapy.
No
The device is described as a high-speed dental handpiece used for restoration procedures in general dentistry, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "high-speed dental handpiece" and describes physical components like a "contra angle," "transmission," and "chucking system," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "restoration procedures" in general dentistry. This involves working directly on the patient's teeth, not analyzing samples from the body.
- Device Description: The device is a dental handpiece used for mechanical procedures (drilling, shaping) on teeth. It does not involve any reagents, test strips, or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly a tool used for physical manipulation during dental procedures, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Products intended for professional use only. Used in general dentistry for restoration procedures.
Lares Research Smoothdrive 1:5 contra angle handpiece is intended for professional use only. The device is used in general dentistry for restoration procedures.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.
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
professional use only. Used in general dentistry.
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)
Performance tests were conducted in-house at Lares Research with production samples of the Smoothdrive 1:5 contra angle. The contra angle motor connection, speed, sound, temperature and chucking mechanism were all evaluated during validation testing. Validation testing concluded the device meets all of the applicable consensus standards.
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right is written in a bold, sans-serif font. The word "FDA" is in a blue box.
November 7, 2022
Lares Research Bruce Holderbein Director of Engineering and Regulatory Affairs 295 Lockheed Ave Chico, California 95973
Re: K220874
Trade/Device Name: Smooth Drive contra angle and straight handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: October 3, 2022 Received: October 11, 2022
Dear Bruce Holderbein:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220874
Device Name Smoothdrive 1:5 contra angle handpiece
Indications for Use (Describe) Products intended for professional use only. Used in general dentistry for restoration procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------- | --------------------------------------------- |
| X | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Submitter
807.92(a)(1)
Lares Research 295 Lockheed Ave Chico, Ca 95973
| Contact person: | Bruce Holderbein |
|---|---|
| Telephone: | 530-345-1767 extension 2862 |
| Date prepared: | September 23, 2022 |
Device Name
807.92(a)(2)
Trade Names:
Common Name: Classification Name:
Regulation Number: Classification Code:
Predicate Devices
Predicate Device (primary): Predicate Device (secondary, for biocompatibility material comparison):
Smoothdrive 1:5 contra angle handpiece
Contra Angle Handpiece Handpiece, Contra-Angle Attachment, Dental 21 CFR 872.4200 EGS
807.92(a)(3)
807.92(a)(4)
Bien Air Dental - CA Classic 1:5 L K983183
KaVo 25 LPA 1:5 contra angle K073478
Device Description
The Lares Research Smoothdrive 1:5 contra angle is a high-speed dental handpiece which is driven by an electrical motor. The device is designed to be connected to ISO 3964 compatible electric motors operating between 0 and 40,000 rpm. The device has a 1:5 speed increasing transmission (identified by the industry standard red ring) which translates to a working end speed of 0 to 200,000 rpm. The device has a push button chucking system is designed to allow convenient bur changing for ISO 1797 type 3 burs.
Bien Air Dental offers their Classic line of electric motor driven handpieces with the same intended use and substantially equivalent device design with model designations of CA 1:5 L contra angle handpieces.
Indications for Use
807.92(a)(5)
4
Page 2 of 3
Lares Research Smoothdrive 1:5 contra angle handpiece is intended for professional use only. The device is used in general dentistry for restoration procedures.
Device Technological Characteristics
Summary Table of Technological Characteristics
| Nonclinical Tests Discussion | |
|---|---|
Nonclinical tests included:
Performance tests were conducted in-house at Lares Research with production samples of the Smoothdrive 1:5 contra angle. The contra angle motor connection, speed, sound, temperature and chucking mechanism were all evaluated during validation testing. Validation testing concluded the device meets all of the applicable consensus standards.
Clinical Test Discussion
No clinical field trials have been conducted with the Lares Research Smoothdrive 1:5 contra angle handpiece.
Conclusion
Information in this submission provides data confirming the Lares Research Smoothdrive 1:5 contra angle handpiece is substantially equivalent to the predicate Bien Air Classic 1:5 L handpiece when used as intended. Both devices are equally safe and effective when used as intended for general dentistry restorative
807.92(b)(1)
807.92(b)(2)
807.92(b)(3)
| Product | Smoothdrive 1:5
contra angle | Classic CA 1:5 L | Kavo 25 L:1.5
contra angle |
|--------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|
| Motor connection | ISO 3964 type 3 | ISO 3964 type 3 | ISO 3964 type 3 |
| Transmission | 1:5 speed increasing | 1:5 speed
increasing | 1:5 speed
increasing |
| Chucking system | Push button ISO
1797 type 3
compatible | Push button ISO
1797 type 3
compatible | Push button ISO
1797 type 3
compatible |
| Motor speed | 0-40k rpm | 0-40k rpm | 0-40k rpm |
| Bur rotating speed | 0-200k rpm | 0-200k rpm | 0-200k rpm |
| Fiber optic | Yes | Yes | Yes |
| Autoclavable | Yes | Yes | Yes |
Bien Air Dental
KaVo 25 LPA 1:5
807.92(a)(6)
5
Section 5 - 510(k) Summary
procedures when coupled to a 0 – 40k rpm ISO 3964 type 3 compatible electric dental motor.