Smooth Drive contra angle and straight handpieces

K220874 · Lares Research · EGS · Nov 7, 2022 · Dental

Device Facts

• Record ID: K220874
• Device Name: Smooth Drive contra angle and straight handpieces
• Applicant: Lares Research
• Product Code: EGS · Dental
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Products intended for professional use only. Used in general dentistry for restoration procedures.

Device Story

High-speed dental handpiece; electric motor-driven; 1:5 speed-increasing transmission; connects to ISO 3964 compatible electric motors (0-40,000 rpm); produces working end speed of 0-200,000 rpm; features push-button chucking system for ISO 1797 type 3 burs; used by dental professionals in clinical settings for restorative procedures; provides mechanical power to rotary instruments; benefits patient through efficient tooth structure removal during dental restorations.

Clinical Evidence

No clinical field trials conducted. Bench testing only; performance validation included motor connection, speed, sound, temperature, and chucking mechanism testing.

Technological Characteristics

1:5 speed-increasing transmission; ISO 3964 type 3 motor connection; ISO 1797 type 3 compatible push-button chucking system; fiber optic illumination; autoclavable; electric motor-driven; 0-200,000 rpm output speed.

Indications for Use

Indicated for professional use in general dentistry for restoration procedures.

Regulatory Classification

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.

Predicate Devices

• Bien Air Dental - CA Classic 1:5 L (K983183)
• KaVo 25 LPA 1:5 contra angle (K073478)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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)

| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | 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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K220874

#### 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)

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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<br>contra angle | Classic CA 1:5 L | Kavo 25 L:1.5<br>contra angle |
|--------------------|----------------------------------------------|----------------------------------------------|----------------------------------------------|
| Motor connection | ISO 3964 type 3 | ISO 3964 type 3 | ISO 3964 type 3 |
| Transmission | 1:5 speed increasing | 1:5 speed<br>increasing | 1:5 speed<br>increasing |
| Chucking system | Push button ISO<br>1797 type 3<br>compatible | Push button ISO<br>1797 type 3<br>compatible | Push button ISO<br>1797 type 3<br>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)

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## Section 5 - 510(k) Summary

procedures when coupled to a 0 – 40k rpm ISO 3964 type 3 compatible electric dental motor.