Diplomat dental operative units are self-contained dental treatment units that contain vacuum system and water supply and separate compressor placed outside the dental unit. These dental operative units are designed to provide air, water, vacuum and electricity to operate various dental hand-pieces, accessories and attachments, and to serve as a base for other dental devices and accessories. Diplomat dental operative units are offered with or without attached dental chairs. When supplied with a dental chair, the chair is intended to properly position a patient to perform different dental procedures. Diplomat dental operative units are to be operated and used by dentists and other legally qualified professionals, and are intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.

Device Description

Diplomat dental operative units are modern, ergonomically designed, dental systems offered in a wide range of models depending on the specific end user requirements. Diplomat dental operative units are AC-powered devices that are intended to supply power to, and serve as a base for, other dental devices and accessories - such as hand-pieces, operating lights, curing lights, ultrasonic instruments, hygiene instruments, etc. - and deliver electric, air, water and vacuum power to them. Diplomat dental operative units are offered either with the patient dental chair or as a free-standing unit without the chair for those end-users with existing patient chairs that they want to use.

AI/ML Overview

This document is a 510(k) summary for Diplomat Dental Operative Units. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new, innovative device feature. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly present in the provided text.

Based on the provided text, here's what can be extracted and inferred:

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

The document does not present explicit acceptance criteria in the typical sense of quantitative targets for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by the demonstration of Substantial Equivalence to a legally marketed predicate device. This means the Diplomat Dental Operative Units are considered acceptable if they are as safe and effective as the predicate device (Sirona C8+Dental Operative Unit).

The table provided in the document compares various features of the Diplomat Dental Operative Units to the C8+Dental Operative Unit:

Features	Diplomat Dental Operative Units	C8+Dental Operative Unit	Substantially Equivalent
510(k)	Pending	K032543
Models	Adept Models: DA 380, DA 370, DA170, DA 130, DA 110;Consul Models: DC 350, DC 310, DC180, DC 170 and DC orthodontic; andLux Models: DL 320, and DL 210	Multiple versions	Similar
Product Code	EIA	EIA	Same
Regulation Number	872.6640	872.6640	Same
Regulation Name	Unit, Operative, Dental	Unit, Operative, Dental	Same
Place of Use	Dental clinic	Dental clinic	Same
Intended Users	Dentists; assistants and hygienists	Dentists; assistants and hygienists	Same
Power Supply	110V/(230 VAC)50/60 Hz	110V/115V/127V/(230 VAC)50/60 Hz	Similar
Utility Supply	Compressed air and water	Compressed air and water	Same
Protection Class	Class 1 equipment	Class 1 equipment	Same
Degree of Protection	Type B of applied parts	Type B of applied parts	Same
Installation	Professionally installed; availablewith chair and cart mountedoptions.	Professionally installed; not availablewith chair and cart mounted options.	Same
Air Pressure	$450 kPa/800 kPa$ (min./max.)	$550 kPa/750 kPa$ (min./max.)	Similar
Water Pressure	$300 kPa/600 kPa$ (min./max.)	$250 kPa/600 kPa$ (min./max.)	Similar
Electrical Safety	IEC 60601-1	IEC 60601-1	Same
EMC	EN 60601-1-2ISO 7494-1	IEC 60601-1-2	Similar
Performance	Diplomat dental operative unitsare self-contained dentaltreatment units that containvacuum system and water supplyand separate compressor placedoutside the dental unit. Thesedental operative units are designedto provide air, water, vacuum andelectricity to operate variousdental hand-pieces, accessoriesand attachments, and to serve as abase for other dental devices andaccessories. Diplomat dentaloperative units are offered by withor without attached dental chairs.When supplied with a dental chair,the chair is intended to properlyposition a patient to performdifferent dental procedures.	The C8 + Dental Operative Unit withaccessories are intended to supplypower to and serve as a base for dentaldevices and accessories. This productincludes a dental chair. The unit isintended for use in the dental clinicenvironment and used by traineddentists and/or dental technicians andassistants. The C8 + Dental OperativeUnit is offered wilt the optional Sivision3, an intraoral camera system intendedto provide the dentist and patient withintraoral video images to view thecondition of the teeth and oral cavity.	Similar
Statement ofIntended Use	Diplomat dental operative units are to be operated and usedby dentists and other legallyqualified professionals, and areintended for use to provide generaldental restorative care and hygieneprocedures in both traditionaldental office settings applicationsby or under the supervision of alicensed dentist or a hygienist if permitted by applicable law.
			Similar

The "reported device performance" is the conclusion that the Diplomat Dental Operative Units are "Substantially Equivalent" to the predicate device, meaning they perform similarly and do not raise new questions of safety or effectiveness. This is based on the comparison of features, intended use, and technological characteristics.

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

The document explicitly states: "Clinical Data: Not applicable to this 510(k) submission." This indicates that no human patient or clinical test set was used to evaluate the device's performance in a clinical setting for this submission. The evaluation was based on Non-Clinical Data - Device Bench Testing in accordance with international standards. Therefore, there is no sample size for a "test set" in the context of clinical data.

The device testing was likely performed by the manufacturer, DIPLOMAT DENTAL, s.r.o. in Slovak Republic, Slovakia. This would be the provenance of the non-clinical data.

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)

Since no clinical data or human test set was used, there were no experts establishing ground truth for such a set. The "ground truth" for non-clinical bench testing would be the compliance with engineering standards by the testing entity, and possibly by third-party laboratories.

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

Not applicable, as no clinical test set was used.

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 submission for a dental operative unit (a piece of equipment), not an AI-powered diagnostic or assistive tool.

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

Not applicable, as this is a dental operative unit, not an algorithm.

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

For the non-clinical data, the ground truth would be the physical and electrical properties and performance characteristics of the device measured against the specifications outlined in the international standards (IEC 60601-1, EN 60601-1-2, ISO 7494-1). This is a form of engineering/technical ground truth.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device. The "training" in this context would be the design and manufacturing processes based on engineering principles and regulatory standards.

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

Not applicable, as this is related to software/AI development. For this device, the "ground truth" for its design and manufacturing (analogous to a training set for an algorithm) would be the established engineering specifications, safety standards, and performance requirements for dental operative units as defined by the relevant international standards (IEC, EN, ISO) and regulatory bodies (FDA). The manufacturer's internal quality control procedures and adherence to these standards would ensure the "ground truth" of the manufactured units.

Summary

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Image /page/0/Picture/0 description: The image shows the text "KISOS 34" written in black ink at the top. Below the text is the logo for Emergo Group. The logo consists of the words "EMERGO GROUP" with a stylized globe in the center and a world map above and below the text.

OCT 3 0 2013

Image /page/0/Picture/1 description: The image shows the logo for Diplomat Dental Solutions. The logo features the word "DIPLOMAT" in bold, sans-serif font, with the words "DENTAL SOLUTIONS" in a smaller font size underneath. Above the word "DIPLOMAT" is a graphic of a series of rectangles that are decreasing in size from left to right. The rectangles are arranged in a diagonal line.

510(K) Summary

Submission Correspondent

Company Name: Company Address:

Company Contact:

Phone: Fax: Submission Date: Website:

Submission Sponsor

Company Name: Company Address:

Country: Phone: Fax: Website:

Device Classification

Device Sponsor: Product Classification Name: Product Code: Regulation Number: Classification Panel: Regulatory Class:

Emergo Group, Inc. 816 Congress Avenue Suite 1400 Austin, TX 78701 Stuart R. Goldman Senior Consultant project.management@emergogroup.com 512.327.9997 512.327.9998 February 11, 2013 www.emergogroup.com

DIPLOMAT DENTAL, s.r.o. Vrbovská cesta 17 921 01 Piešťany Slovak Republic Slovakia 421.33.7954111 421.33.7726326 www.chirana.sk

DIPLOMAT DENTAL, s.r.o. Unit, Operative Dental EIA 872.6640 Dental Devices Class I

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Image /page/1/Picture/0 description: The image shows the logo for Diplomat Dental Solutions. The logo features the word "DIPLOMAT" in bold, sans-serif font, with the words "DENTAL SOLUTIONS" in a smaller font size underneath. Above the word "DIPLOMAT" is a graphic of a series of rectangles that are stacked diagonally, creating a step-like pattern. The logo is black and white.

Predicate Device

Sirona C8+Dental Operative Unit (K032543)

Statement of Intended Use

Device Description

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Image /page/2/Picture/0 description: The image shows a logo for Diplomat Dental Solutions. The logo features a stylized graphic of interconnected rectangles, resembling a staircase or a series of steps, positioned above the word "DIPLOMAT" in bold, sans-serif font. Below "DIPLOMAT" are the words "DENTAL SOLUTIONS" in a smaller font size.

Diplomat Dental Operative Units:

Adept DA 380, Adept DA 370, Adept DA 130, Adept DA 130, Adept DA 110A, Consul DC 350, Consul DC 310, Consul DC 180, Diplomat Consul DC 170, Diplomat Consul DC 170 (Orthodontic), Diplomat Lux DL 320; Diplomat Lux DL 210

Diplomat Dental Accessories:

Dental Chair DE 20, Dental Chair DM 20, Dental Stools D 10L, Dental Light Xenos, Dental Light Sirius

Predicate Device Comparison

Diplomat dental operative units by DIPLOMAT DENTAL have been shown to be Substantially Equivalent to the C8+Dental Operative Units manufactured by Sirona Dental Systems previously cleared by the FDA under K032543. The applicant and predicate devices are very similar in overall design and technology; principle of operation, intended use, materials, construction, and available accessories offered for them. The differences between the applicant and predicate devices do not raise any new questions of safety or effectiveness. Some select properties and characteristics of the applicant and predicate devices are compared side-by-side in the table below.

Features	Diplomat DentalOperative Units	C8+DentalOperative Unit	SubstantiallyEquivalent
510(k)	Pending	K032543
Models	Adept Models: DA 380, DA 370, DA170, DA 130, DA 110;Consul Models: DC 350, DC 310, DC180, DC 170 and DC orthodontic; andLux Models: DL 320, and DL 210	Multiple versions	Similar
Product Code	EIA	EIA	Same
RegulationNumber	872.6640	872.6640	Same
RegulationName	Unit, Operative, Dental	Unit, Operative, Dental	Same
Place of Use	Dental clinic	Dental clinic	Same
IntendedUsers	Dentists; assistants and hygienists	Dentists; assistants and hygienists	Same
Power Supply	110V/(230 VAC)50/60 Hz	110V/115V/127V/(230 VAC)50/60 Hz	Similar
Utility Supply	Compressed air and water	Compressed air and water	Same

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ABARAGEBAABABABARAHAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA

:
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ENTAL SOLUTIONSN 100

ProtectionClass	Class 1 equipment	Class 1 equipment	Same
Degree ofProtection	Type B of applied parts	Type B of applied parts	Same
Installation	Professionally installed; availablewith chair and cart mountedoptions.	Professionally installed; not availablewith chair and cart mounted options.	Same
Air Pressure	$450 kPa/800 kPa$ (min./max.)	$550 kPa/750 kPa$ (min./max.)	Similar
WaterPressure	$300 kPa/600 kPa$ (min./max.)	$250 kPa/600 kPa$ (min./max.)	Similar
ElectricalSafety	IEC 60601-1	IEC 60601-1	Same
EMC	EN 60601-1-2ISO 7494-1	IEC 60601-1-2	Similar
Performance	Diplomat dental operative unitsare self-contained dentaltreatment units that containvacuum system and water supplyand separate compressor placedoutside the dental unit. Thesedental operative units are designedto provide air, water, vacuum andelectricity to operate variousdental hand-pieces, accessoriesand attachments, and to serve as abase for other dental devices andaccessories. Diplomat dentaloperative units are offered by withor without attached dental chairs.When supplied with a dental chair,the chair is intended to properlyposition a patient to performdifferent dental procedures.Diplomat dental operativeunits are to be operated and usedby dentists and other legallyqualified professionals, and areintended for use to provide generaldental restorative care and hygieneprocedures in both traditionaldental office settings applicationsby or under the supervision of a	The C8 + Dental Operative Unit withaccessories are intended to supplypower to and serve as a base for dentaldevices and accessories. This productincludes a dental chair. The unit isintended for use in the dental clinicenvironment and used by traineddentists and/or dental technicians andassistants. The C8 + Dental OperativeUnit is offered wilt the optional Sivision3, an intraoral camera system intendedto provide the dentist and patient withintraoral video images to view thecondition of the teeth and oral cavity.	Similar
Statement ofIntended Use
of a licensed dentist or a hygienist if permitted by applicable law.

EMERGO O GROUP

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Image /page/4/Picture/0 description: The image shows the logo for Diplomat Dental Solutions. The logo features the word "DIPLOMAT" in large, bold, sans-serif font, with the words "DENTAL SOLUTIONS" in a smaller font below it. Above the word "DIPLOMAT" is a graphic of a series of rectangles that are arranged in a diagonal line.

Non-Clinical Data - Device Bench Testing

As part of demonstrating the safety and effectiveness of its line of Diplomat dental operative units, DIPLOMAT DENTAL has submitted these devices for performance testing in accordance with the applicable sections of the following international standards and FDA guidance documents:

. IEC 60601-1:2005, Medical electrical equipment - Part 1, General requirements for basic safety and essential performance
. EN 60601-1-2:2007, Medical electrical equipment – Part 1-2, General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
. EN 60601-1:2009, Medical electrical equipment - Part 1, General reguirements for basic safety and essential performance
. ISO 7494-1:2004, Dentistry - Dental Units - Part 1: General requirements and test methods

Clinical Data

Not applicable to this 510(k) submission.

Substantially Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and

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Image /page/5/Picture/0 description: The image shows a logo for "DIPLOMAT DENTAL SOLUTIONS". The word "DIPLOMAT" is in large, bold, sans-serif font, with "DENTAL SOLUTIONS" in a smaller font size underneath. Above the word "DIPLOMAT" is a graphic consisting of a series of connected, progressively smaller, rectangles. The rectangles are arranged in a descending, step-like pattern.

that the new device does not raise new questions regarding its safety and effectiveness when compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the Diplomat dental operative units by DIPLOMAT DENTAL when compared to the Sirona Dental Systems C8+Dental Operative Units (K032543) are minimal and do not raise any questions regarding their safety and effectiveness. Diplomat dental operative units, as designed and manufactured are therefore determined to be substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

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

October 30, 2013

Diplomat Dental, S.R.O. C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K130534

Trade/Device Name: Dental Operative Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: September 23, 2013 Received: September 24, 2013

Dear Mr. Goldman:

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.

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Page 2 - Mr. Goldman

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySTBohner-S

Kwame Ulmer M.S.

Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Devices Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

K130534 510(k) Number (if Known):

Prescription Use X

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew Steens
2013.10.30 21:30:21 -04'00'

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.