Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical and electrical components, and there is no mention of AI or ML in the provided text.

Therapeutic

No.

The device descriptions and intended uses do not mention any therapeutic claims or functions. It is used for surgical and preparation procedures in dentistry, which are interventional rather than therapeutic.

Diagnostic

No
The device is described as a handpiece used for various dental surgical and preparation procedures, such as tooth extraction, osteotomy, and cavity preparation. Its function is to perform physical alterations to tissue (e.g., cutting, drilling), not to diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "electrical-driven SURGmatic S15 L Pro handpiece" and describes physical components like a fiber optic light system, electrical motor, gear, and a collet for holding a bur. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, the SURGmatic S15 L Pro handpiece is not an In Vitro Diagnostic (IVD) device.

Here's why:

Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Intended Use: The intended use of the SURGmatic S15 L Pro is for surgical procedures directly on the patient's oral, jaw, and facial structures (tooth extraction, root resection, osteotomy, etc.). It interacts directly with the patient's body, not with specimens taken from the body.
Device Description: The description details a mechanical device that uses a rotating bur to perform physical actions on teeth and bone. It does not describe any components or processes related to analyzing biological samples.

Therefore, the SURGmatic S15 L Pro is a surgical dental handpiece, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

EGS

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral, jaw and facial.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained professional in the field of general dentistry and/or oral surgery

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)

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.
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
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
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K140308

Reference Device(s)

K073478

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

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-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.

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

| Descriptive
Information | Subject Device
SURGmatic S15 L Pro | Primary Predicate
Device
SURGmatic (K140308) | Reference Device
SUPERtorque,
GENTLEpower
Handpieces and
Attachement
(K073478) | Comparison |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | KaVo Dental GmbH | KaVo Dental GmbH | KaVo Dental GmbH | Same |
| Pictorial
Representation | | | | N/A |
| Regulatory Classification | | | | |
| Regulation # | 21 CFR §872.4200 | 21 CFR §872.4200 | 21 CFR §872.4200 | Same |
| Regulation Title | Dental Handpiece and
Accessories | Dental Handpiece and
Accessories | Dental Handpiece and
Accessories | Same |
| Regulation Class | Class I | Class I | Class I | Same |
| Product Code | EGS | EBW / EGS | EFB | Similar to
Primary
Predicate |
| Indications for
Use | Indications for Use / 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
| The medical device is
intended for the following
uses: Surgery such as
setting an implant, bone
augmentation, sinus lift,
tooth extraction
procedures, implantology,
osteotomia, root
resection and oral, jaw
and facial surgery. | The GENTLEpower
Handpieces and
Attachments are
intended for the removal
of carious material,
excess filling material,
reducing hard tooth
structure, cavity and
crown preparation, root
canal preparation,
finishing tooth
preparations,
restorations and for
polishing teeth. They are
designed for use by a
trained professional in
the field of general
dentistry. | Same as
Primary
Predicate and
Reference
Device with
the only
difference
being choice
of similar
wording. |
| Intended Use | The electrical-driven
SURGmatic S15 L Pro
handpiece is a dental
handpiece 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 electrical-driven
SURGmatic handpieces
are dental handpieces in
accordance with 21 CFR §
872.4200 (dental
handpieces and
accessories) and is only
intended for dental
treatment. | The GENTLEpower
Handpieces and
Attachments are dental
instruments for use by a
trained professional in
general dentistry. The
handpieces and
attachments are
powered by either an
air-motor or electric
motor. | Same |
| Device Design | | | | |
| Principles of
Operation | 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 | Through the micro motor
connected to the dental
treatment unit the
contra-angle handpieces
equipped with a
handpiece connection
according to ISO 3964
(Dentistry - Coupling
dimensions for handpiece
connectors - ISO
3964:1982) receives the
energy, the cooling water
and air for treatment and | Through the micro
motor connected to the
dental treatment unit
the contra-angle
handpieces equipped
with a handpiece
connection according to
ISO 3964 (Dentistry -
Coupling dimensions for
handpiece connectors -
ISO 3964:1982)
receives the energy, the
cooling water and air for | Similar to
Primary
Predicate and
Reference
Device |
| | 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. | the light for illumination
the operating area. | treatment and the light
for illumination the
operating area. | |
| Air / water ports | External spray which is
transferred internally into the
spray insert | External Spray | Internal Spray | Similar to
Primary
Predicate and
Reference
Device |
| Composition of Materials | | | | |
| Direct / Indirect
patient-
contacting
materials | Stainless Steel
Pad printing ink
Glass Rod Fiber | Stainless Steel | Stainless Steel | Similar to
Primary
Predicate and
Reference
Device |
| Technical Specifications | | | | |
| Light
illumination | Fibreoptic | Fibreoptic | Fibreoptic | Same |
| Dimension | Headsize-High: 14.7mm
Headsize-Diameter: 10.2mm
Handpiece length: 97.5mm | Headsize-High: 13.8mm
Headsize-Diameter: 9.8mm
Handpiece length: 96.5mm | Headsize-Height: 24mm
Headsize-Diameter:
10.5mm
Handpiece length: 80-100mm | Similar to
Primary
Predicate and
Reference
Device |
| Type of chuck | Push Button | Push Button, lever chuck | Push Button | Same as
Reference
Device |
| Power Source | Electric Motor | Electric Motor | Electric Motor | Same |
| Dental Bur | Burs in accordance with ISO
1797-1 can be used | Burs in accordance with
ISO 1797-1 can be used | Burs in accordance with
ISO 1797-1 can be used | Same |
| Speed Range | Up to 40,000 rpm | Up to 40,000 rpm | High-speed: Approx.
200,000 rpm
Low-speed: 100 -
40,000 rpm | Same as
Primary
Predicate |
| Light Intensity | Approx. 25,000 Lux | Approx. 25,000 Lux | Approx. 25,000 Lux | Same |
| Lubricant | | | | Same |
| Automated
handpiece
Lubricant system | KaVo QUATTROcare (K071288) | KaVo QUATTROcare
(K071288) | KaVo QUATTROcare
(K071288) | Same |
| | KaVo Spray America | KaVo Spray America | KaVo Spray America | Same |
| Lubricant | QUATTROcare Plus Spray
America | QUATTROcare Plus Spray
America | QUATTROcare Plus
Spray America | |
| | (K071288) | (K071288) | (K071288) | |
| Performance Testing | | | | |
| Complies to
Standards | Complies with:
ISO 14457 (Dentistry -
Handpieces and motors) | Complies with:
ISO 14457 (Dentistry -
Handpieces and motors) | Complies with:
ISO 7785-2 (Dental
handpieces - Part 2: | Same |
| | | | | |
| | ISO 1797 (Dentistry - Shanks
for rotary and oscillating
instruments)
ISO 3964 (Dentistry - Coupling
dimensions for handpiece
connectors) | ISO 1797-1 (Dentistry -
Shanks for rotary
instruments - Part 1:
Shanks made of metals)
ISO 3964 (Dentistry -
Coupling dimensions for
handpiece connectors) | Straight and geared
angle handpieces)
ISO 1797 (Dentistry -
Shanks for rotary
instruments)
ISO 3964 (Dentistry -
Coupling dimensions for
handpiece connectors) | |
| Sterilization | Sterilizable according to ISO
17665-1 (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 | Sterilizable according to
ISO 17665-1
(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 | Sterilizable according to
ISO 17665-1
(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 | Same |
| Biocompatibility | Biocompatible according to ISO
10993-1
(Biological evaluation of
medical devices - Part 1:
Evaluation and testing within a
risk management system). | Biocompatible according
to ISO 10993-1
(Biological evaluation of
medical devices - Part 1:
Evaluation and testing
within a risk management
system). | Biocompatible according
to ISO 10993-1
(Biological evaluation of
medical devices - Part 1:
Evaluation and testing
within a risk
management 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.