K Number

Device Name

Manufacturer

KaVo Dental GmbH

Date Cleared

2021-12-21

(85 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K073478,K140308

Predicate For

N/A

Intended Use

The SURGmatic S15 L Pro handpiece is intended for:

Oral, jaw and facial surgery
Tooth extraction procedures
Root resection
Osteotomy
Removal of carious material
Tooth, cavity and crown preparations
Processing of fillings

The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

Device Description

The electrical-driven SURGmatic S15 L Pro handpieces in accordance with 21 CFR § 872.4200 (dental handpieces and accessories) designed for use by a trained professional in the field of general dentistry only. The device is an electrically driven handpiece that is reusable and provided with a fiber optic light system. The electrical motor includes the light source and the SURGmatic S15 L Pro handbiece is provided with a fiber optic light transmitter to transport the light to the bur side. DIN EN ISO 14457 requlates the minimum illuminance. The dental handpieces can be sterilized in a steam sterilizer (autoclave). SURGmatic handpieces equipped with a handpiece connector in accordance with ISO 3964 are connected to a treatment unit by means of a hose and the electrical motor and receive the energy for the gear, cooling water and air for conservative dental treatment as well as the light for illumination of the operation area through corresponding output openings. Burs in accordance with ISO 1797-1 must be used with the SURGmatic handpieces. Based on the INTRAmatic connection that meets the ISO 3964 standard, the SURGmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The SURGmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.

The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).

The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental handpiece (SURGmatic S15 L Pro). Unlike submissions for AI/ML-driven medical devices that involve complex algorithms and require extensive performance studies, this document focuses on demonstrating substantial equivalence to existing predicate devices based on common technological characteristics, intended use, and adherence to established international standards.

Therefore, many of the questions regarding acceptance criteria and performance studies in the context of AI/ML or diagnostic devices (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of device submission.

The document primarily relies on non-clinical bench testing against recognized industry standards to demonstrate that the new device performs comparably to its predicates and meets safety and performance requirements.

Here's an attempt to answer the questions based on the information available in the document, highlighting where the requested details are not relevant to this type of device:

1. A table of acceptance criteria and the reported device performance

The document does not present specific "acceptance criteria" in the format of quantitative thresholds for device performance against a particular medical outcome, as might be seen for an AI diagnostic tool. Instead, acceptance is demonstrated by adherence to established international standards for dental handpieces and by demonstrating substantial equivalence to predicate devices in typical performance characteristics.

The "reported device performance" is implicitly demonstrated through the device complying with the standards listed. The acceptance criteria are the criteria outlined in these standards.

Acceptance Criteria (Demonstrated by Compliance with Standards)	Reported Device Performance (Implied by Compliance)
Biocompatibility: Meets ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405	The device materials are biocompatible and do not pose a biological risk to patients.
Mechanical Performance: Meets ISO 14457 (Dentistry - Handpieces and motors)	The handpiece meets mechanical performance specifications, including bur retention, torque, speed, and durability.
Sterilization: Sterilizable according to ISO 17665-1 (Moist heat sterilization), AAMI / ANSI ST79	The device can be safely and effectively sterilized for repeated use in a clinical setting.
Ergonomics & Compatibility: Meets ISO 3964 (Coupling dimensions), ISO 1797 (Shanks for rotary and oscillating instruments)	The handpiece connects properly to dental motors and accepts standard dental burs.
Light Illumination: Meets DIN EN ISO 14457 minimum illuminance (approx. 25,000 Lux)	The fiber optic light system provides adequate illumination of the operating area.
Risk Management: ISO 14971 (Application of risk management to medical devices)	Risks associated with the device have been identified, evaluated, and controlled.
Usability: IEC 62366-1 (Application of usability engineering)	The device is designed to be safe and effective for use by trained professionals.
Processing Information: ISO 17664 (Information to be provided for processing)	The manufacturer provides clear instructions for processing (e.g., cleaning, sterilization) of the device.

The document states: "Performance bench testing according to international standards for Dental Handpieces has been conducted to determine conformance..." and lists the standards. This implies that the device met the requirements of these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified in terms of patient or clinical samples, as this was a non-clinical, bench-testing submission. The "test set" would refer to the physical units of the device tested in the lab. The document describes "Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device," which implies a sample of devices tested. The exact number is not provided.
Data provenance: Not explicitly stated regarding origin or type (retrospective/prospective), as it's non-clinical bench testing. The manufacturer, KaVo Dental GmbH, is based in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. For a dental handpiece, "ground truth" as it relates to diagnostic accuracy or clinical outcomes is not established by human experts in the same way as for an AI/ML algorithm. Performance is assessed against engineering specifications and international standards through bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations (e.g., ground truth for image-based diagnostics), which is not relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a mechanical dental instrument, not a diagnostic AI/ML system, and therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a standalone mechanical device. The concept of "algorithm only" or "human-in-the-loop" performance does not apply. The device's "standalone" performance is assessed by its ability to meet the non-clinical performance standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For a dental handpiece, the "ground truth" for performance relates to engineering specifications and international standards. For example, bur extraction force must meet a minimum specified in DIN EN ISO 14457; light illumination must meet DIN EN ISO 14457. Biocompatibility is "ground-truthed" by adherence to ISO 10993 series. There isn't a "pathology" or "outcomes data" ground truth in the same sense as for a diagnostic device.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. Not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

December 21, 2021

KaVo Dental GmbH Kerstin Henseler Regulatory Affairs Manager Bismarckring 39 Biberach, 88400 GERMANY

Re: K213139

Trade/Device Name: SURGmatic S15 L Pro Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: September 24, 2021 Received: September 27, 2021

Dear Kerstin Henseler:

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.

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

{1}------------------------------------------------

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 (OS) 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, 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 Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213139

Device Name SURGmatic S15 L Pro

Indications for Use (Describe)

The SURGmatic S15 L Pro handpiece is intended for:

Oral, jaw and facial surgery
Tooth extraction procedures
Root resection
Osteotomy
Removal of carious material
Tooth, cavity and crown preparations
Processing of fillings

The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Kavo Dental Excellence. The logo consists of the word "KAVO" in a bold, sans-serif font, with the "A" stylized to resemble a dental tool. Below the word "KAVO" is the phrase "Dental Excellence" in a smaller, lighter font. The logo is simple and modern, and it conveys a sense of professionalism and quality.

510(k) Summary K213139

SURGmatic S15 L Pro handpiece

1. Submitter Information:
  KaVo Dental GmbH Bismarckring 39 88400 Biberach, Germany

Contact Person: E-Mail: Telephone Number: Kerstin Henseler kerstin.henseler@kavo.com (+49) 7351-56-2431

Date Prepared: September 24, 2021

1. Device Name:

• Proprietary Name:	SURGmatic S15 L Pro
---------------------	---------------------

. KaVo Dental GmbH Manufacturer:
Dental handpiece, Contra-Angle Attachment Common Name: ●
o Classification Name: Dental Handpiece and Accessories
CFR Number: 21 CFR §872.4200 ●
. Device Class: 1
Product Code: EGS ●

3. Predicate Device:

Predicate Device (Primary):

Proprietary Name: SURGmatic (K140308) o
Manufacturer: KaVo Dental GmbH O
0 Common Name: Dental Handpiece, Contra-Angle Attachment
Classification Name: Dental Handpiece and Accessories O
- 872.4200 CFR Number:
Device Class: I O
Product Code: EBW, EGS 0

Reference Device:

O Proprietary Name: SUPERtorque, GENTLEpower Handpieces (K073478)
Manufacturer: KaVo Dental GmbH O
Common Name: Dental Handpiece, Air-Powered O
Classification Name: Dental Handpiece and Accessories O
CFR Number: 872.4200 O
O Device Class: I
EFB Product Code: O

{4}------------------------------------------------

4. Description of Device:

The electrical motor rotates with an idle speed of 40.000 1/min and the gear ratio of the SURGmatic S15 L Pro instrument amounts to 1:5 (exactly 1:4,71).

The bur is held in the rotating head drive with the help of a collet and can be released by a push-button mechanism. DIN EN ISO 14457 requlates the minimum extraction force of the bur.

Principle of Operation / Mechanism of Action:

Rotatory movement. Surgical instruments for the mouth, jaw and facial surgery are straight and contra-angle handpieces which are powered by electrical surgical motors. Electrical energy is converted into mechanical energy through the motor. This mechanical energy is transferred to the drive trains in the contra-angle handpiece in the form of a rotary movement via a coupling interface in accordance with DIN EN ISO 3964. The force is transmitted through shafts and gear components to another coupling interface located in the head housing, which is designed for safe insertion and removal of tools in accordance with DIN EN ISO 1797. The mechanical energy is passed on to the cutting part of these tools and thus to the treatment site by this interface.

5. Indications for Use:

The SURGmatic S15 L Pro handpiece is intended for:

Oral, jaw and facial surgery
Tooth extraction procedures
Root resection
Osteotomy
Removal of carious material
Tooth, cavity and crown preparations
Processing of fillings

The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and/or oral surgery.

{5}------------------------------------------------

6. Description of Substantial Equivalence:

Details of the similarities between subject and predicate device:

The similarities between the subject and predicate device is mainly the indications for use and the intended use with the only difference being choice of similar wording. It can be said that the handpieces are for use in the field of general dentistry and/or oral surgery. Furthermore, equally similar is the drive by a motor, which drives trains in the contra-angle handpiece in the form of a rotary movement via a coupling interface in accordance with DIN EN ISO 3964. The force is transmitted through shafts and qear components to another coupling interface located in the head housing. Technical Specifications like light illumination, type of chuck, power source, dental bur, speed range, light intensity are the same. To maintain the handpiece the same automated handpiece lubricant system and lubricant are used. The SURGmatic S15 L Pro handpiece has the same type of chuck as the both predicate devices which is push button.

Furthermore, the proposed device and the predicate devices complies with performance standards ISO 14457; Dentistry - Handpieces and motors as well as Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system).

Details of the differences between subject and predicate device:

There are no major differences however there are a few minor differences such as the course of air and water ports, direct and indirect patient-contacting materials and dimensions. The SURGmatic S15 L Pro handpiece is available with External spray which is transferred internally into the spray insert. The other handpieces have an external spray instead. For all handpieces the material stainless steel is used for nearly all direct and indirect patient-contacting parts with the only difference by identifying now also the pad printing ink & the qlass rod fiber as a direct / indirect patient-contacting part. The dimensions differ in a few millimeters.

Conclusion:

Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the SURGmatic S15 L Pro handbiece is deemed to be substantially equivalent to the predicate devices as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: (1) Indications for Use, (2) Technological Characteristics, and (3) Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.

Device Comparison Table:

Table 5.1

DescriptiveInformation	Subject DeviceSURGmatic S15 L Pro	Primary PredicateDeviceSURGmatic (K140308)	Reference DeviceSUPERtorque,GENTLEpowerHandpieces andAttachement(K073478)	Comparison
Manufacturer	KaVo Dental GmbH	KaVo Dental GmbH	KaVo Dental GmbH	Same
PictorialRepresentation				N/A
Regulatory Classification
Regulation #	21 CFR §872.4200	21 CFR §872.4200	21 CFR §872.4200	Same
Regulation Title	Dental Handpiece andAccessories	Dental Handpiece andAccessories	Dental Handpiece andAccessories	Same
Regulation Class	Class I	Class I	Class I	Same
Product Code	EGS	EBW / EGS	EFB	Similar toPrimaryPredicate
Indications forUse	Indications for Use / Intended Use
	The SURGmatic S15 L Prohandpiece is intended for:- Oral, jaw and facial surgery- Tooth extraction procedures- Root resection- Osteotomy- Removal of carious material	The medical device isintended for the followinguses: Surgery such assetting an implant, boneaugmentation, sinus lift,tooth extractionprocedures, implantology,osteotomia, rootresection and oral, jawand facial surgery.	The GENTLEpowerHandpieces andAttachments areintended for the removalof carious material,excess filling material,reducing hard toothstructure, cavity andcrown preparation, rootcanal preparation,finishing toothpreparations,restorations and forpolishing teeth. They aredesigned for use by atrained professional inthe field of generaldentistry.	Same asPrimaryPredicate andReferenceDevice withthe onlydifferencebeing choiceof similarwording.
Intended Use	The electrical-drivenSURGmatic S15 L Prohandpiece is a dentalhandpiece in accordance with21 CFR § 872.4200 (dentalhandpieces and accessories)designed for use by a trainedprofessional in the field ofgeneral dentistry only.	The electrical-drivenSURGmatic handpiecesare dental handpieces inaccordance with 21 CFR §872.4200 (dentalhandpieces andaccessories) and is onlyintended for dentaltreatment.	The GENTLEpowerHandpieces andAttachments are dentalinstruments for use by atrained professional ingeneral dentistry. Thehandpieces andattachments arepowered by either anair-motor or electricmotor.	Same
Device Design
Principles ofOperation	Electrical energy is convertedinto mechanical energythrough the motor. Thismechanical energy istransferred to the drive trainsin the contra-angle handpiecein the form of a rotarymovement via a couplinginterface in accordance withDIN EN ISO 3964. The force istransmitted through shafts andgear components to another	Through the micro motorconnected to the dentaltreatment unit thecontra-angle handpiecesequipped with ahandpiece connectionaccording to ISO 3964(Dentistry - Couplingdimensions for handpiececonnectors - ISO3964:1982) receives theenergy, the cooling waterand air for treatment and	Through the micromotor connected to thedental treatment unitthe contra-anglehandpieces equippedwith a handpiececonnection according toISO 3964 (Dentistry -Coupling dimensions forhandpiece connectors -ISO 3964:1982)receives the energy, thecooling water and air for	Similar toPrimaryPredicate andReferenceDevice
	the head housing, which isdesigned for safe insertion andremoval of tools in accordancewith DIN EN ISO 1797. Themechanical energy is passedon to the cutting part of thesetools and thus to the treatmentsite by this interface.	the light for illuminationthe operating area.	treatment and the lightfor illumination theoperating area.
Air / water ports	External spray which istransferred internally into thespray insert	External Spray	Internal Spray	Similar toPrimaryPredicate andReferenceDevice
Composition of Materials
Direct / Indirectpatient-contactingmaterials	Stainless SteelPad printing inkGlass Rod Fiber	Stainless Steel	Stainless Steel	Similar toPrimaryPredicate andReferenceDevice
Technical Specifications
Lightillumination	Fibreoptic	Fibreoptic	Fibreoptic	Same
Dimension	Headsize-High: 14.7mmHeadsize-Diameter: 10.2mmHandpiece length: 97.5mm	Headsize-High: 13.8mmHeadsize-Diameter: 9.8mmHandpiece length: 96.5mm	Headsize-Height: 24mmHeadsize-Diameter:10.5mmHandpiece length: 80-100mm	Similar toPrimaryPredicate andReferenceDevice
Type of chuck	Push Button	Push Button, lever chuck	Push Button	Same asReferenceDevice
Power Source	Electric Motor	Electric Motor	Electric Motor	Same
Dental Bur	Burs in accordance with ISO1797-1 can be used	Burs in accordance withISO 1797-1 can be used	Burs in accordance withISO 1797-1 can be used	Same
Speed Range	Up to 40,000 rpm	Up to 40,000 rpm	High-speed: Approx.200,000 rpmLow-speed: 100 -40,000 rpm	Same asPrimaryPredicate
Light Intensity	Approx. 25,000 Lux	Approx. 25,000 Lux	Approx. 25,000 Lux	Same
Lubricant				Same
AutomatedhandpieceLubricant system	KaVo QUATTROcare (K071288)	KaVo QUATTROcare(K071288)	KaVo QUATTROcare(K071288)	Same
	KaVo Spray America	KaVo Spray America	KaVo Spray America	Same
Lubricant	QUATTROcare Plus SprayAmerica	QUATTROcare Plus SprayAmerica	QUATTROcare PlusSpray America
	(K071288)	(K071288)	(K071288)
Performance Testing
Complies toStandards	Complies with:ISO 14457 (Dentistry -Handpieces and motors)	Complies with:ISO 14457 (Dentistry -Handpieces and motors)	Complies with:ISO 7785-2 (Dentalhandpieces - Part 2:	Same

	ISO 1797 (Dentistry - Shanksfor rotary and oscillatinginstruments)ISO 3964 (Dentistry - Couplingdimensions for handpiececonnectors)	ISO 1797-1 (Dentistry -Shanks for rotaryinstruments - Part 1:Shanks made of metals)ISO 3964 (Dentistry -Coupling dimensions forhandpiece connectors)	Straight and gearedangle handpieces)ISO 1797 (Dentistry -Shanks for rotaryinstruments)ISO 3964 (Dentistry -Coupling dimensions forhandpiece connectors)
Sterilization	Sterilizable according to ISO17665-1 (Sterilization of healthcare products – Moist heat –Part 1: Requirements for thedevelopment, validation androutine control of a sterilizationprocess for medical devices onthe final, finished device	Sterilizable according toISO 17665-1(Sterilization of healthcare products – Moistheat - Part 1:Requirements for thedevelopment, validationand routine control of asterilization process formedical devices on thefinal, finished device	Sterilizable according toISO 17665-1(Sterilization of healthcare products - Moistheat - Part 1:Requirements for thedevelopment, validationand routine control of asterilization process formedical devices on thefinal, finished device	Same
Biocompatibility	Biocompatible according to ISO10993-1(Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management system).	Biocompatible accordingto ISO 10993-1(Biological evaluation ofmedical devices - Part 1:Evaluation and testingwithin a risk managementsystem).	Biocompatible accordingto ISO 10993-1(Biological evaluation ofmedical devices - Part 1:Evaluation and testingwithin a riskmanagement system).	Same

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Non-Clinical Test Data:

Performance bench testing according to international standards for Dental Handpieces has been conducted to determine conformance in regards to:

. Biocompatibility has been completed for the applicable components.
o Comparative performance testing of the functions of the Proposed device compared to the cleared stand-a-lone device.

Furthermore, the performance of the SURGmatic S15 L Pro has been verified utilizing the following standards:

ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and o testing within a risk management process.
. ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010: Biological evaluation of medical devices -Part 10: Tests for irritation . and skin sensitization.
ISO 7405:2018 Dentistry Evaluation of biocompatibility of medical devices used in ● dentistry.
ISO 14971:2007: Medical devices Application of risk management to medical devices. ●
IEC 62366-1:2015-02: Medical devices Part 1: Application of usability engineering to ● medical devices [Including CORRIGENDUM 1 (2016)]
. ISO 17664:2017: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
. ISO 14457:2017: Dentistry - Handpieces and motors

{9}------------------------------------------------

. AAMI / ANSI ST79:2017: Comprehensive quide to steam sterilization and sterility assurance in health care facilities
ISO 3964:2016: Dentistry - Coupling dimensions for handpiece connectors
ISO 1797:2017: Dentistry - Shanks for rotary and oscillating instruments
o ISO 17665-1:2006: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final, finished device

Clinical Performance Data:

Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.

Conclusion as to Substantial Equivalence:

Based on a comparison of intended use, indications, technological characteristics, principle of operation, and performance data, the SURGmatic S15 L Pro is deemed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.