The UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit intended to supply power to and serve as a base for other dental devices and instruments. The system is indicated for performing general dental procedures. The device is intended for operation and use in a clinical setting by legally qualified professionals.

Device Description

The new UNICLINE MOBILE is an electrically powered, self-contained mobile dental operative unit consisting of a mobile cart, foot control, internal water supply containers, suction, and mobile patient chair. It contains a foot control that allows the dental professional to engage the features using only the foot. Instrument status is viewable in a single place using a multi-display feature. The instrument arms are spring balanced for ease of use and the extra long connection hoses have been designed for use in any position. The new UNICLINE MOBILE is designed to ensure patient comfort and safety in any of the chair positions. The handles, instrument support, and upholstery are easy to disassemble and clean. The unit uses compressed air and water, and includes a suction element. The cart contains the motors that operate the instrument connections. There are two movable arms that protrude from the top of the cart. One arm contains the optional OEM dental operating lamp that the dentist can position to light the area being worked on. The other arm supports an instrument table. The table contains five spring-loaded smaller arms, an instrument tray, and the instrument display. The new UNICLINE MOBILE spring-loaded arms connect with OEM dental instruments and provide power to them. Once connected, the display indicates whether the air and water spray are on, the time, and the speed of the active motor. The display also includes a timer for use with a light polymerization instrument. The dental professional uses the foot control to operate all functions and instruments of this dental operative unit. The unit was designed for mobility and ease of positioning. The cart is made of fire retardant medium density fiberboard (MDF) coated with paint and its two arms are made of anodized, lacquered aluminum. All selected materials are biocompatible. The chair is made with casted aluminum and imitation leather upholstery. Both the cart and chair contain wheels on one side to allow each piece to be positioned for optimal use of available floor space before connecting via the stabilizing plate.

AI/ML Overview

The provided document is a 510(k) summary for the UnicLine Mobile dental operative unit. It focuses on demonstrating substantial equivalence to a predicate device, the Aseptico AMC 20 Mobile Dental System, rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance.

Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this type of submission. The document mainly discusses compliance with recognized standards and a comparison of features with a predicate device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in the way a clinical study would for efficacy. Instead, it demonstrates compliance with recognized non-clinical performance standards and compares its features to a predicate device.

Acceptance Criteria (based on standards/comparison)	Reported Device Performance (Compliance/Similarity)
Non-Clinical Performance Data
IEC 60601-1 (General safety)	Device complies with this standard.
IEC 60601-1-2 (EMC)	Device complies with this standard.
IEC 60601-1-6 (Usability)	Device complies with this standard.
IEC 62366 (Usability Engineering)	Device complies with this standard.
IEC 80601-2-60 (Dental equipment specific safety)	Device complies with this standard.
ISO 7494-2 (Water & air supply)	Device complies with this standard.
ISO 7494-1 (General requirements & test methods)	Device complies with this standard.
ISO 21530 (Resistance to chemical disinfectants)	Device complies with this standard.
ISO 6875 (Patient Chair)	Device complies with this standard.
Biocompatibility
Direct patient contacting materials	Biocompatible (upholstery same as reference device K081699).
Indirect patient contacting materials	Comply with 21 CFR 177.2600.
Software
FDA Guidance for Premarket Submission for Software	Software validated and complies with guidance.
IEC 62304 (Software life cycle)	Software validated and complies with this standard.
Comparison to Predicate Device
Indications for Use	Similar - no new question of safety and effectiveness.
Product Code, Regulation Number, Name	Same.
Intended Users, Environment of Use	Same.
Protection Class, Degree of Protection	Same.
Power Supply	Similar - no new question of safety or effectiveness.
Frequency	Same.
Utility Supply	Same.
Electrical Safety, EMC, Display	Same.
Materials	Similar - no new question of safety or effectiveness (Fire retardant MDF. Aluminum vs. Stainless Steel, Aluminum, Plastic).
Dimensions, Weight	Similar - no new question of safety or effectiveness.
Features	Differences noted (optional lamp, instrument arm mounting to chair) but explained as not raising new questions of safety or effectiveness.
Air Pressure	Same.
Water Supply - Flow Rate	Same (0.15 liter/min).
Suction Connection - Flow Rate	Similar - no new question of safety or effectiveness (67.0 - 80.0 Liters/Min vs. 42.3 – 189.7 liters/min).

The "study" that proves the device meets requirements is the set of non-clinical performance bench tests detailed above, which verified compliance with relevant IEC and ISO standards.

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

Sample Size: Not applicable in the context of this 510(k) summary. The "test set" for the non-clinical performance and engineering tests would be the device itself or components of the device. These tests are conducted on the manufactured product to verify design specifications and compliance with standards.
Data Provenance: The tests are "Performance bench testing" which are conducted by the manufacturer, Heka Dental A/S (Denmark). The data would be prospective, as it's generated specifically for the submission.

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

Not applicable. For non-clinical performance and engineering tests against standards (e.g., electrical safety, EMC, material biocompatibility), the "ground truth" is adherence to the published specifications of those standards. This does not typically involve expert consensus on clinical cases.

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

Not applicable. Adjudication methods like 2+1 are used for clinical studies involving interpretation of medical images or patient outcomes, not for engineering bench tests.

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 dental operative unit (hardware), not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This device 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 performance tests, the "ground truth" is adherence to the specifications within the referenced international and national standards (e.g., IEC 60601-1, ISO 7494-2). For biocompatibility, it's compliance with 21 CFR 177.2600 and material equivalence to a known reference device. For software, it's compliance with FDA Guidance and IEC 62304.

8. The sample size for the training set

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

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

Not applicable.

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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

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

April 17, 2015

Heka Dental A/S c/o Mr. Dave Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza. Suite 2000 New York, NY 1011

Re: K150490

Trade/Device Name: UnicLine Mobile Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 3, 2015 Received: April 6, 2015

Dear Mr. Yungvirt:

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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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 (QS) 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/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 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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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Heka Dental - Unicline Mobile Traditional 510(k)

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) Not Yct Known. K150490

Device Name UnicLine Mobile

Ind1catlons for Use (Describe)

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

l:8J Prescription Use (Part 21 CFR 801 Subpart D)

O 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 STAFFEMAIL 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 Druq 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 OMS number. •

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Image /page/3/Picture/0 description: The image shows the logo for Heka Dental. The logo is in black and gray, with the word "heka" in black and the word "dental" in gray. Above the logo is some text that reads "+HND 'HQWDO - 8QLF/LQH 0RELOH 7UDGLWLRQDO 510(N)".

SECTION 5: 510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92

510(k) Summary

Date Prepared:	February 12, 2015
Submitter:	HEKA DENTAL A/SBaldershøj 38DK-2635 IshøjDenmark.Telephone: +45 43 32 09 90Facsimile: +45 43 32 09 80
Contact:Trade/ProprietaryName of Device:	Cynthia J. Pillar, RACPhone: 1 (773) 677-8886
	UNICLINE MOBILE
Common Nameof Device:	Dental Operative Unit
Classification:	Class I per 21 CFR 872.6640, Operative Unit, Dental,Product Code EIA
Legally MarketedPredicateDevice:	Aseptico AMC 20 Mobile Dental System, K101332) Class Iper 21 CFR 872.6640, Operative Unit, Dental, Product CodeEIA, manufactured by Aseptico, Inc.
ReferenceDevice:	Planmeca Sovereign Dental Operative Unit, K081699 ClassI per 21 CFR 872.6640, Operative Unit, Dental, ProductCode EIA, manufactured by Planmeca USA, Inc.

Description of New UNICLINE MOBILE Device:

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Image /page/4/Picture/0 description: The image shows the word "hekadental" in a stylized font, with the "heka" part in black and the "dental" part in gray. Above the word, there is some text that appears to be a product code or some other identifier, such as "+HND 'HQWDO - 801 F/L OH ORFI OF". The text is in a smaller font size and is aligned to the right of the word "hekadental".

the chair positions. The handles, instrument support, and upholstery are easy to disassemble and clean.

The unit uses compressed air and water, and includes a suction element. The cart contains the motors that operate the instrument connections. There are two movable arms that protrude from the top of the cart. One arm contains the optional OEM dental operating lamp that the dentist can position to light the area being worked on. The other arm supports an instrument table. The table contains five spring-loaded smaller arms, an instrument tray, and the instrument display. The new UNICLINE MOBILE spring-loaded arms connect with OEM dental instruments and provide power to them. Once connected, the display indicates whether the air and water spray are on, the time, and the speed of the active motor. The display also includes a timer for use with a light polymerization instrument. The dental professional uses the foot control to operate all functions and instruments of this dental operative unit.

The unit was designed for mobility and ease of positioning. The cart is made of fire retardant medium density fiberboard (MDF) coated with paint and its two arms are made of anodized, lacquered aluminum. All selected materials are biocompatible. The chair is made with casted aluminum and imitation leather upholstery. Both the cart and chair contain wheels on one side to allow each piece to be positioned for optimal use of available floor space before connecting via the stabilizing plate.

Intended Use/Indications for Use of the New Device:

The indications for use statements of the new UNICLINE MOBILE device and the predicate Aseptico AMC 20 Mobile Dental System device are nearly identical. The new UNICLINE MOBILE indications for use statement includes specific information concerning its use environment, use of instruments, and intended users. This information also applies to the predicate device, but they are not included in the indications for use statement. In addition, the new UNICLINE MOBILE is indicated for general procedures without additionally specifying endodontic procedures, as general procedures encompass general endodontic procedures. These differences are not critical to the intended use of the new UNICLINE MOBILE device, nor do they affect the performance of the device when used as labeled.

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Image /page/5/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with "heka" in black and "dental" in gray. Above the logo, there is some text that appears to be a product code or identifier, reading '+HND 'HQWDO - 8QLF/LQH 0RELOH'. The text is in a smaller font size and is right-aligned relative to the logo.

Comparison of the Technological Features of the New Device and Predicate Device:

We believe that the new UNICLINE MOBILE device has been shown to be substantially equivalent to the predicate Aseptico AMC 20 Mobile Dental System (K101332). The new and predicate devices are very similar in overall design and technology, principles of operation, intended use, materials, construction, and compatibility with OEM instruments. Main differences are as follows:

1. The new UNICLINE MOBILE cart can be purchased with an optional OEM dental operating lamp and arm that connects to the cart. The predicate AMC 20 Mobile Dental System (K101332) does not offer this optional feature.
1. The new UNICLINE MOBILE cart contains an instrument arm and is mounted to a mobile patient dental chair designed specifically for the new UNICLINE MOBILE device. The predicate device contains instrument mounts directly on the side of the cart and does not mount to a dental chair. The two devices are similar since both are used with a dental chair and mounted instruments and both must be stable in order for safe and effective use.

The differences between the new UNICLINE MOBILE device and the predicate Aseptico AMC 20 Mobile Dental System device do not raise any new questions.. Shown in TABLE 5.1 below are some select properties and characteristics of the new UNICLINE MOBILE and the predicate Aseptico AMC 20 Mobile Dental System device compared side-by-side.

DESCRIPTIVEINFORMATION	NEW UNICLINEMOBILE DENTALOPERATIVE UNIT	PREDICATE DEVICE:Aseptico AMC 20Mobile DentalSystem (K101332)	SubstantialEquivalence
Indications forUse	The UNICLINEMOBILE is anelectricallypowered, self-contained mobiledental operativeunit intended tosupply power toand serve as abase for otherdental devices andinstruments. Thesystem is indicated	The AMC-20 is amobile self-containeddental system that isused for endodonticand general dentistryapplications.	Similar - Nonew questionof safety andeffectiveness
	for performinggeneral dentalprocedures. Thedevice is intendedfor operation anduse in a clinicalsetting by legallyqualifiedprofessionals.
Product Code	EIA	EIA	Same
RegulationNumber	872.6640	872.6640	Same
RegulationName	Unit, Operative,Dental	Unit, Operative, Dental	Same
Intended Users	Dentists, Assistants& Hygienists	Dentists, Assistants &Hygienists	Same
Environment ofUse	Clinical Setting	Clinical Setting	Same
Protection Class	Class 1 equipment	Class I equipment	Same
Degree ofProtection	Type B of appliedpartsType BFEquipment	Type B of appliedpartsType BF Equipment	Same
Power Supply	120V/230V50/60Hz electricalsupply	100V/220V at60Hz/50Hz	Similar - nonew questionof safety oreffectiveness.
Frequency	Mains Frequency:50/60Hz	Mains Frequency:50/60Hz	Same
Utility Supply	Compressed Airand Water	Compressed Air andWater	Same
Electrical Safety	IEC 60601-1	IEC 60601-1	Same
EMC	EN 60601-1-2	IEC 60601-1-2	Same
Display	LED	LED	Same
Materials	Fire retardant MDF,Aluminum	Stainless Steel,Aluminum, Plastic(Fire Retardant MDF -unknown)	Similar - nonew questionof safety oreffectiveness
Dimensions(Installed)	Cart: 22.8" W x26.2" L x 34.3" H	Cart: 23.5" W x 30.0"L x 36.5" H	Similar - nonew questionof safety oreffectiveness
Weight	Cart 90Kg (198 lbs)(Chair 95Kg)	71.7Kg (158 lbs)(OEM Chair Unknown)	Similar - nonew question
	Total 185Kg)		of safety oreffectiveness
Features	2 motors for OEMinstruments3-way air/watersyringeSelf-containedwater systemAir supplySuctionFoot ControlMovable armsDental OperatingLamp	2 motors for OEMinstruments3-way air/watersyringeSelf-contained watersystemAir supplySuctionFoot Control	Difference -seeexplanation1. above forlamp & 2.above for themovableinstrumentarm
Dental Chair	Cart mounts toHeka Dental chair	Cart does not mount tochair	Difference -seeexplanation2. above
Air Pressure	65 - 88psi — defaultsetting110 psi - max	110psi	Same
Water Supply -Flow Rate	0.15 liter/min	5.07 fl. oz./min (0.15liter/min)	Same
SuctionConnection -Flow Rate	67.0 - 80.0Liters/Min	42.3 – 189.7 liters/min	Similar - nonew questionof safety oreffectiveness

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Image /page/6/Picture/0 description: The image shows the logo for Heka Dental. The word "heka" is in black font, while "dental" is in gray. To the right of the logo is some text that appears to be a product code or some other identifier, which reads "+HND 'HQWDO - 8QLF/LQH ORELOH 7UDGLWLRQDO 510(N)".

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Image /page/7/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with the "heka" portion in black and the "dental" portion in gray. Above the logo, there is some text that appears to be technical or product-related information, including '+HND 'HQWDO - 8QLF/LQH 0RELOH 7UDGEWLRODO 5100'. The text is smaller and less prominent than the logo.

TABLE 5.1

Testing:

Non-Clinical Performance Data Testing:

Performance bench testing was conducted to verify that the new UNICLINE MOBILE device meets all design specifications and demonstrates substantial equivalence to its predicate Aseptico AMC 20 Mobile Dental System (K101332). The results of testing demonstrate that the new UNICLINE MOBILE device complies with the following standards:

IEC 60601-1 Medical electrical equipment part 1, General o requirements for safety
IEC 60601-1-2 Medical electrical equipment part 1-2, General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility, Requirements and tests

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. IEC 60601-1-6 - Medical electrical equipment - Part 1-6: General Requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366 - Medical devices - Application of usability engineering to medical devices
IEC 80601-2-60 - Medical electrical equipment - Part 2: Particular requirements for basic safety and essential performance of dental equipment
ISO 7494-2 Dentistry Dental Units Part 2: Water and air supply ●
ISO 7494-1 Dentistry Dental Units Part 1: General requirements and o test methods
. ISO 21530 - Dentistry - Materials used for dental equipment surfaces -Determination of resistance to chemical disinfectants
ISO 6875 Dentistry Patient Chair ●

Biocompatibility:

The new UNICLINE MOBILE direct and indirect patient contacting materials are biocompatible. The direct patient contacting upholstery is the same material and color as used in reference device, the Planmeca Sovereign Dental Operative Unit, K081699. The indirect patient contacting materials comply with 21 CFR 177.2600.

Software:

In addition, the software has been validated and complies with the FDA Guidance for the content of Premarket Submission for Software Contained in Medical Devices as well as IEC 62304: 2006. Medical device software -Software life cycle processes.

Risk Analysis:

Risk management activities were performed throughout development of the new UNICLINE MOBILE unit. Potential individual risks were identified, evaluated, and mitigated to the extent possible. Remaining overall residual risk was assessed and determined that any remaining risk is as low as possible and is outweighed by the benefits of the new UNICLINE MOBILE.

Clinical Performance Testing:

No clinical testing has been performed in support of this UNICLINE MOBILE 510(k) submission.

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Image /page/9/Picture/0 description: The image shows the logo for "hekadental" in a stylized font, with the "heka" portion in bold black and the "dental" portion in a lighter gray. Above the logo, there is some text that appears to be a product code or identifier, reading "+HND 'HQWDO - 8QLF/LQH 0RELOH". The text is in a smaller font size compared to the logo.

Conclusion:

The conclusions drawn from the specifications and performance testing of the new UNICLINE MOBILE device demonstrate that the new UNICLINE MOBILE device is at least as safe and as effective and performs as well as the predicate Aseptico AMC 20 Mobile Dental System (K101332). For these reasons, we believe the new UNICLINE MOBILE device is substantially equivalent to the predicate device.

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.