The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Device Description

The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).

AI/ML Overview

The request asks for a detailed description of acceptance criteria and the study proving the device meets these criteria. However, the provided document is a 510(k) premarket notification for a dental handpiece (SMARTmatic), which focuses on demonstrating substantial equivalence to a predicate device rather than on specific acceptance criteria and a detailed study proving performance against those criteria.

The document primarily highlights the substantial equivalence of the SMARTmatic handpieces to the MASTERmatic LUX handpieces (K143465) based on intended use, technological characteristics, and performance data. It relies on conformance to various ISO standards and a guiding document for dental handpieces. The document does not contain information on:

A specific table of acceptance criteria with reported device performance against numerical targets.
Sample sizes for a test set or data provenance (as it's not a clinical study on diagnostic accuracy).
Number of experts, their qualifications, or adjudication methods for ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance (as it's a mechanical device, not an AI algorithm).
Sample size for a training set or how ground truth for a training set was established.

Therefore, many of the requested points cannot be extracted from this document as they are not relevant to a 510(k) submission for a dental handpiece.

However, I can extract information related to the performance data and "acceptance" from the perspective of substantial equivalence and adherence to recognized standards.

Here's the information that can be extracted and a clear indication of what is not present:

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

The document doesn't provide a table of acceptance criteria in the sense of specific numerical thresholds for performance metrics. Instead, it relies on conformance to international standards. The "Summary of the Technological Characteristics" table ([page 7] and [page 8]) compares the new device (SMARTmatic) to the predicate device (MASTERmatic LUX) across various design and technical specifications. The "acceptance criteria" here are effectively that the new device's characteristics are either the same as the predicate or, if different, that these differences do not raise new questions of safety or effectiveness, as demonstrated by non-clinical testing to relevant standards.

Summary of Technological Characteristics and Performance (as presented in the document):

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

None stated directly. The document refers to "Performance bench testing according to international standards." This typically involves testing a defined number of device units or components, but the specific sample sizes are not provided in this summary.
Data Provenance: Not explicitly stated, but the manufacturer is Kaltenbach & Voigt GmbH, based in Biberach, Germany. The tests are "Non-Clinical Test Data," indicating lab/bench testing, not data from human subjects. This would be considered prospective bench testing.

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. This information is for clinical studies or AI algorithm validation, not for a mechanical dental handpiece undergoing bench testing for substantial equivalence.

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

Not applicable. This is for clinical studies/AI algorithm validation.

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 device is a mechanical dental handpiece, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical device, not an algorithm. Bench testing was done for the device itself.

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

For biocompatibility: Conformance to ISO 10993-1. The "ground truth" is that the materials used meet the specified biocompatibility standards.
For mechanical performance (e.g., bur retention force, speed range, coupling dimensions): Conformance to relevant ISO standards (e.g., ISO 14457, ISO 1797-1, ISO 3964). The "ground truth" is whether the physical measurements and operational parameters of the device meet the requirements of these standards.
For sterilization: Conformance to ISO 17665-1 and AAMI ANSI ST79. The "ground truth" is that the sterilization process specified for the device achieves the required sterility assurance levels.

8. The sample size for the training set

Not applicable. This refers to AI/machine learning models.

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

Not applicable. This refers to AI/machine learning models.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance bench testing program to demonstrate substantial equivalence to a legally marketed predicate device (MASTERmatic LUX K143465).

Methodology: Performance bench testing according to international standards (listed below) and biocompatibility and sterilization studies.
Standards utilized for performance verification:
- ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
- ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals)
- ISO 7405 / ISO 10993-1 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
- ISO 14457 (Dentistry - Handpieces and motors)
- ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1)
- AAMI ANSI ST79 (Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities)
- Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions.
Conclusion: The tests demonstrated that despite some differences in technological characteristics (e.g., external vs. internal spray, presence/absence of fiber optics, speed range, specific chuck types, and minor dimensions), these differences do not raise new concerns regarding substantial equivalence to the predicate device. The SMARTmatic handpieces are deemed substantially equivalent based on intended use, indications, technological characteristics, principle of operation, features, and performance data derived from these non-clinical tests.
Clinical Data: The document explicitly states: "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."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

Kaltenbach & Voigt GmbH Stefan Trampler Director Regulatory Affairs Bismarckring 39 Biberach, 88400 GERMANY

Re: K163239 Trade/Device Name: SMARTmatic Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EFA Dated: February 14, 2017 Received: February 15, 2017

Dear Stefan Trampler:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education 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.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K163239

Device Name SMARTmatic

Indications for Use (Describe)

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 (8/14)

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Image /page/3/Picture/0 description: The image features the KaVo Dental Excellence logo. The logo consists of the text "KaVo. Dental Excellence" in a simple font. To the right of the text is a stylized graphic, possibly representing dental tools or abstract shapes, rendered in a metallic blue color.

Section V - 510(k) Summary

Submitter:

Kaltenbach & Voigt GmbH Bismarckring 39 88400 Biberach Stefan Trampler - Contact Person 49 (7351) 56 3515 - Phone number +49 (7351) 56 7 3515 - Facsimile

Date Summary Prepared: February 14, 2017

Device Name:

Trade Name SMARTmatic .
Common Name Handpiece, belt and/or gear driven, dental ●
Classification Name - Dental handpiece and accessories, per 21 CFR § 872.4200
. Device Class - Class I
Product Code EFA ●

Devices for Which Substantial Equivalence is Claimed:

MASTERmatic LUX (K143465) marketed by Kaltenbach & Voigt GmbH.

Trade Name MASTERmatic LUX ●
Common Name Handpiece, belt and/or gear driven, dental ●
Classification Name Dental Handpiece and Accessories, per 21 CFR & 872.4200 ●
Device Class - Class I
Product Code EFA ●

Device Description:

Device	Detailed Description
SMARTmatic S10	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a straighthandpiece for the use of dental burs and other attachmentsaccording to ISO 1797-1.

SMARTmatic S10 K	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a straighthandpiece with a reduced diameter at the back of thehandpiece (K) for the use of dental burs and otherattachments according to ISO 1797-1.
SMARTmatic S10 S	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a straighthandpiece with external spray (S) for the use of dental bursand other attachments according to ISO 1797-1.
SMARTmatic PROPHY S19	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a straighthandpiece for the use of prophylaxis heads with a Doriotconnector according to ISO 14457.
SMARTmatic PROPHY S19 K	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a straighthandpiece with a reduced diameter at the back of thehandpiece (K) for the use of prophylaxis heads with a Doriotconnector according to ISO 14457.
SMARTmatic S20	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of dental burs and otherattachments according to ISO 1797-1.
SMARTmatic S20 K	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece with a reduced diameter at the back (K) ofthe handpiece for the use of dental burs and otherattachments according to ISO 1797-1.
SMARTmatic S20 S	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece with external spray (S) for the use of dentalburs and other attachments according to ISO 1797-1.
SMARTmatic S80 K	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece with a reduced diameter at the back of thehandpiece (K) for the use of dental burs and otherattachments according to ISO 1797-1.
SMARTmatic ENDO S81	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of dental burs and otherattachments according to ISO 1797-1 and has a ratio of 8:1for endodontic purposes.
Elements 8:1	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of dental burs and otherattachments according to ISO 1797-1 and has a ratio of 8:1.
SMARTmatic ENDO S321	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of dental burs and otherattachments according to ISO 1797-1 and has a ratio of 32:1for endodontic purposes.
SMARTmatic S53	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of dental burs and otherattachments according to ISO 1797-1 for prophylaxis andendodontic purposes.
SMARTmatic PROPHY S31	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of prophy cups or polishingbrushes according to ISO 13295 for support (spindle) type 5.
SMARTmatic PROPHY S31 K	This model attaches to a dental motor according to ISO 14457 withcoupling per ISO 3964 and represents a contra-angle handpiece andhas a reduced diameter at the back of the handpiece (K) for the useof prophy cups or polishing brushes according to ISO 13295 forsupport (spindle) type 5.
SMARTmatic PROPHY S33	This model attaches to a dental motor according to ISO14457 with coupling per ISO 3964 and represents a contra-angle handpiece for the use of prophy cups or polishingbrushes according to ISO 13295 for support (spindle) type 5.

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Per the Guidance for Industry and FDA Staff; Bundling Multiple Indications in a Sinqle Submission, dated June 22, 2007, Kaltenbach and Voigt GmbH is bundling the SMARTmatic models listed above as the models do not differ significantly in purpose, design, materials, energy source, function or any other feature related to safety and effectiveness. The device description and intended use are identical for all configuration models. All critical components within the SMARTmatic dental handpieces are common. The minor differences between the models are cosmetic in nature such as straight or contra-angle design, size / shape of the handpiece, with / without external water spray, and bur movement.

The different electrical motors (i.e. INTRAmatic LUX KL 702) utilized with the SMARTmatic handpieces, are registered with the different dental treatment units (K103027 in the case of INTRAmatic LUX KL 702). Based on the INTRAmatic connection that meets the ISO 3964:1982 standard (Dentistry - Coupling dimensions for handpiece connectors), the SMARTmatic handpieces fit with any electrical dental motor which is produced in accordance to this standard. The different electrical motors will not be delivered together with the SMARTmatic handpieces. The electrical motors carry the gear, the gear, the cooling water and air for cutting treatment from the dental treatment unit to the SMARTmatic handpieces.

Accessories:

Additionally, the SMARTmatic handpiece models equipped with external spray will be supplied with a jet needle. The straight handpieces SMARTmatic S10 / S10 K / S10 S are equipped with a drill bit stop and a hook for removal of the drill. Dental burs and other attachments that meets the ISO 1797-1:2011 standard (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals) may be inserted into the chuck system of the SMARTmatic handpieces for applicable cutting operations based on the intended use. The Accessories are for informational purposes only.

Jet Needle:

Description of the Principle of Operation / Mechanism of Action The Jet Needle is used ● to clean the spray lines of the devices when necessary.
A description of proposed conditions of use / How used with the SMARTmatic The . operator will use the Jet Needle by inserting it into the water line to uncloq any blockage.

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Drill Bit Stop (Bur Stop) (SMARTmatic S10 / S10 K / S10 S):

Description of the Principle of Operation / Mechanism of Action The Drill Bit Stop (Bur ● Stop) is used when using contra-angle burs in a straight handpiece.
. A description of proposed conditions of use / How used with the SMARTmatic – The operator will open the handpiece chuck then insert the bur stop in the chuck. The operator will then press the contra-angle bur onto the bur stop and then close the clamping ring making sure that it is firmly seated.

Hook (SMARTmatic S10 / S10 K / S10 S):

Description of the Principle of Operation / Mechanism of Action The Hook is used by ● the operator when removing the Bur Stop.
A description of proposed conditions of use / How used with the SMARTmatic When a . contra-angle bur is used that requires a Drill Bit Stop (Bur Stop), the Hook is required to remove the Bur Stop out of the chuck after use.

Mechanism of Action:

The SMARTmatic dental handpieces are electrical-driven handpieces which will be supplied with energy, water and air through the tube and the electrical motor of a dental treatment unit. Based on the speed adjusted in the dental treatment unit the handpiece bur rotates up to 40,000 rom. The SMARTmatic handpieces interact with the patient through a rotating bur with the patient teeth according to the intended use.

Statement of Intended Use:

The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Substantial Equivalence:

The SMARTmatic handpieces function in a manner similar to and are intended for the same use as the MASTERmatic LUX handpieces (K143465) marketed by Kaltenbach & Voigt GmbH. The SMARTmatic handpieces are similar to the predicate device (K143465) in that they are dental electrical-driven handpieces for the use by a trained professional in the field of general dentistry. The SMARTmatic handpieces are substantially equivalent in design, application and function to the predicate device (K143465). Both the MASTERmatic LUX handpieces (K143465) and the SMARTmatic handpieces are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Dental burs and cutters (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011) can be used for both, the SMARTmatic handpieces and the MASTERmatic LUX handpieces (K143465). In addition, both handpiece types, the SMARTmatic handpieces and the MASTERmatic LUX handpieces (K143465) are equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) and receive the energy for the gear, the cooling water and air for cutting treatment through the tube and the specific electrical motor connected to a dental unit as the mechanism of action.

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The SMARTmatic handpieces differ from the MASTERmatic LUX handpieces (K143465) in dimensions, speed range, type of chuck, fiber optics and the supply of spray. The SMARTmatic handpieces are only available with external spray (according to the model). The SMARTmatic handpieces are not available with a fiber optic light system. The speed range of the SMARTmatic handpieces which is up to 40.000 rpm differs from the speed range of the MASTERmatic LUX handpieces (200.000 rpm). Some models of the SMARTmatic handpieces are also available with a different type of chuck. Both devices have small differences in the dimensions (see Table - Summary of the Technological Characteristics).

The performance tests demonstrate that the differences in technological characteristics do not raise different concerns reqarding substantial equivalence to the predicate device. Hence, the SMARTmatic handpieces are substantial equivalent to the MASTERmatic LUX handpieces.

In summary, the SMARTmatic handpieces with the indications for use and intended use described in this submission are substantially equivalent to the MASTERmatic LUX handpieces cleared under K143465. It also 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.

Summary of the Technological Characteristics:

DescriptiveInformation	SMARTmatic	MASTERmatic LUX (K143465)from Kaltenbach & Voigt GmbH
Indications for Use
Indications for Use	The SMARTmatic handpieces areintended for the removal of cariousmaterial, reducing of hard toothstructure, cavity and crownpreparations, root canal preparations,removal of fillings, processing andfinishing tooth preparations,restorations, and for polishing teeth.They are designed for use by a trainedprofessional in the field of generaldentistry.	The MASTERmatic LUX handpieces areintended for the removal of cariousmaterial, reducing of hard toothstructure, cavity and crownpreparations, root canal preparations,removal of fillings, processing andfinishing tooth preparations,restorations, and for polishing teeth.They are designed for use by a trainedprofessional in the field of generaldentistry.
Device Design
Functional Principle	Through the micro motor connectedto the dental treatment unit thestraight and contra-angle handpiecesequipped with a handpiece connectionaccording to ISO 3964 (Dentistry -Coupling dimensions for handpiececonnectors - ISO 3964:1982) receivesthe energy, the cooling water and airfor treatment and the light forillumination the operating area.	Through the micro motor connected tothe dental treatment unit the straightand contra-angle handpieces equippedwith a handpiece connection accordingto ISO 3964 (Dentistry - Couplingdimensions for handpiece connectors -ISO 3964:1982) receives the energy,the cooling water and air for treatmentand the light for illumination theoperating area.
Operational Modes	N/A - Standard	N/A - Standard
Air / water ports	No Spray / External Spray	Internal Spray
Fiberoptics	Without light system	With built-in light system
Dimensions	Head size-Height: Up to 13,6 mmHead size-Diameter: Up to 9,8 mmLength: Up to 93,4 mm	Head size-Height: Up to 13,6 mmHead size-Diameter: Up to 10,2 mmLength: Up to 95,9 mm
Type of chuck	Push Button, Twist-tension Chuck, Snap-on & Screw-in	Push Button, Twist-tension Chuck
Coupling Dimensions	Dimensions comply with ISO 3964(Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982)	Dimensions comply with ISO 3964(Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982)
Accessories	Jet Needle, Drill Bit Stop (Bur Stop), Hook, Dental Burs and Prophylaxis Heads	Jet Needle, Drill Bit Stop (Bur Stop), Hook and Dental Burs
Rotary Instruments	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011).	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011).
Composition of Materials
Direct patient-contacting portions of the device	All materials for the SMARTmatic models are listed in the tables below including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009)	Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009)
Indirect patient-contacting portions of the device (water / air lines)	All materials for the SMARTmatic models are listed in the tables below including chemical composition of the waterlines and the patient-contacting portions of the device. Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009)	Biocompatible according to ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system - ISO 10993-1:2009)
Technical Specifications
Chuck Design	Push Button, Twist-tension Chuck,Snap-on & Screw-in	Push Button, Twist-tension Chuck
Light Intensity	N/A	25,000 Lux
Bur Retention Force	Min. 22 N (45 N straight handpieces)	Min. 22 N (45 N straight handpieces)
Bur Extraction Force	15N - 52N	15N - 52N
Maximum Air Pressure	29 psi	29 psi
Maximum Water Pressure	29 psi	29 psi
Speed Range (RPM's)	Up to 40,000 rpm	Up to 200,000 rpm
Conformance Standards (Handpieces and Motors)	ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012)	ISO 14457 (Dentistry - Handpieces and motors - ISO 14457:2012)
Conformance Standards (Shanks)	ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011)	ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals - ISO 1797-1:2011)
Conformance Standards (Coupling Dimensions)	ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982)	ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982)
Conformance Standards (Hose Connections)	N/A - For air driven handpieces only.	N/A - For air driven handpieces only.
Sterilization	Sterilisable 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 - ISO 17665-1:2006)	Sterilisable 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 - ISO 17665-1:2006)
Lubricant	KaVo QUATTROcare (K071288)	KaVo QUATTROcare (K071288)

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Non-Clinical Test Data:

Performance bench testing according to international standards for dental handpieces and accessories (handpiece, belt and/or gear driven) has been conducted to determine conformance. Biocompatibility and sterilization studies has been completed for the applicable components. Hence the SMARTmatic demonstrates substantial equivalence.

The performance of the SMARTmatic handpieces has been verified utilizing the following standards:

ISO 3964 1982-12-00 Dentistry Coupling dimensions for handpiece connectors ●
. ISO 1797-1 - 2011-08-00 - Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals
ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical ● devices used in dentistry / ISO 10993-1 - 2009-10-00 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
. ISO 14457 - 2012-09-15 - Dentistry - Handpieces and motors
ISO 17665-1 2006-08-15 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
AAMI ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive Guide ● To Steam Sterilization And Sterility Assurance In Health Care Facilities
. Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions - 2007-05-02

Clinical Test 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 wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.

Conclusion:

Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the SMARTmatic 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.

Descriptive Information	SMARTmatic	MASTERmatic LUX (Predicate)
Indications for Use	The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.	The MASTERmatic LUX handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Functional Principle	Through the micro motor connected to the dental treatment unit, the handpieces receive energy, cooling water, air for treatment, and light (for illumination) (Note: SMARTmatic does not have fiber optics).	Through the micro motor connected to the dental treatment unit, the handpieces receive energy, cooling water, air for treatment, and light for illumination the operating area.
Air / Water Ports	No Spray / External Spray (according to model)	Internal Spray
Fiberoptics	Without light system	With built-in light system
Dimensions	Head size-Height: Up to 13.6 mmHead size-Diameter: Up to 9.8 mmLength: Up to 93.4 mm	Head size-Height: Up to 13.6 mmHead size-Diameter: Up to 10.2 mmLength: Up to 95.9 mm
Type of Chuck	Push Button, Twist-tension Chuck, Snap-on & Screw-in	Push Button, Twist-tension Chuck
Coupling Dimensions	Dimensions comply with ISO 3964	Dimensions comply with ISO 3964
Accessories	Jet Needle, Drill Bit Stop (Bur Stop), Hook, Dental Burs and Prophylaxis Heads	Jet Needle, Drill Bit Stop (Bur Stop), Hook and Dental Burs
Rotary Instruments	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1.	For Burs, Cutters and other attachments (with straight handpiece shank or with contra-angle shank) according to ISO 1797-1.
Biocompatibility	Biocompatible according to ISO 10993-1 for both direct and indirect patient-contacting portions. Materials listed in tables (not provided in this excerpt).	Biocompatible according to ISO 10993-1 for both direct and indirect patient-contacting portions.
Chuck Design	Push Button, Twist-tension Chuck, Snap-on & Screw-in	Push Button, Twist-tension Chuck
Light Intensity	N/A (without light system)	25,000 Lux
Bur Retention Force	Min. 22 N (45 N straight handpieces)	Min. 22 N (45 N straight handpieces)
Bur Extraction Force	15N - 52N	15N - 52N
Maximum Air Pressure	29 psi	29 psi
Maximum Water Pressure	29 psi	29 psi
Speed Range (RPM's)	Up to 40,000 rpm	Up to 200,000 rpm
Conformance Standards	ISO 14457, ISO 1797-1, ISO 3964, ISO 10993-1, ISO 17665-1, AAMI ANSI ST79	ISO 14457, ISO 1797-1, ISO 3964, ISO 10993-1, ISO 17665-1
Sterilization	Sterilizable according to ISO 17665-1	Sterilizable according to ISO 17665-1
Lubricant	KaVo QUATTROcare (K071288)	KaVo QUATTROcare (K071288)