(135 days)
Not Found
No
The summary describes a device that uses mechanical vibration to facilitate tooth movement and does not mention any AI or ML components or functions.
Yes
The device is described as "an orthodontic accessory for the treatment of tooth malocclusion" and "helps facilitate minor anterior tooth movement," indicating it is used to treat a medical condition.
No
The device description states that the product is an "orthodontic accessory for the treatment of tooth malocclusion" and is "used by patients for twenty minutes per day in conjunction with standard orthodontic treatment." The intended use indicates it "helps facilitate minor anterior tooth movement." There is no mention of the device being used to diagnose, detect, or identify any condition or disease.
No
The device description and performance studies clearly indicate the presence of hardware components (mouthpiece, battery, firmware, Bluetooth, etc.) that are integral to the device's function, not just software.
Based on the provided information, the AcceleDent® Optima is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for facilitating tooth movement during orthodontic treatment, which is a physical process applied to the body.
- Device Description: The device is described as an "orthodontic accessory" used by patients in conjunction with standard orthodontic treatment.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) outside of the body. The performance studies listed are related to the device's physical and electrical safety and functionality, not diagnostic testing of biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AcceleDent® Optima does not fit this description.
N/A
Intended Use / Indications for Use
AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Product codes (comma separated list FDA assigned to the subject device)
OYH
Device Description
The AcceleDent® Optima is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Optima should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The table below lists all performance testing performed on the AcceleDent® Optima to ensure its safety and efficacy.
- Biocompatibility: The biocompatibility testing consisted of the following tests: Cytotoxicity, Intracutaneous Reactivity Irritation, Maximization Sensitization, and ISO/USP Acute System Toxicity. Reference ISO 10993-5:2009 (E), ISO 10993-10:2010(E). The purpose of the biocompatibility testing was to verify that the users of the AcceleDent 3G/Optima device will not experience any biological adverse reactions due to the product material, color, and manufacturing process. AcceleDent® Optima passed Biocompatibility testing.
- Bioburden Enumeration: Since this test was conducted for study purposes only, there was no identified acceptance criteria. The bioburden testing was performed on the 3G mouthpiece and activator to determine the total number of viable microorganisms on the medical device. AcceleDent® Optima passed Bioburden Enumeration testing.
- System Verification: This testing verified that the full system requirements, which includes the medical device hardware and optional/external mobile application and cloud server software, met the requirements serving as enhancements over Aura. The scope of the testing is to verify that the 3G product met all of its system requirements. The system is comprised of the Activator, Charging Case, Cloud App, Mobile App, and Web Portal. AcceleDent® Optima passed System Verification testing.
- Firmware Unit Test Verification: No standards were utilized in this testing. The design requirements for the AcceleDent® Optima firmware was tested. The purpose of this test was to verify the firmware requirement were met by firmware design. AcceleDent® Optima passed Firmware Unit Verification testing.
- SubSystem Test Verification: This testing verified that the medical device hardware met the performance requirements of Aura for therapeutic force delivery, battery charging, usage logging, and environmental operation without the interface of optional/external software (i.e. mobile application, cloud server). The scope of this testing is to verify that the physical components of the 3G AcceleDent System function as intended. Devices under Test (DUT) are the Activator and Charging Case Assembly, AC Power Wall Adapter, Cable. AcceleDent® Optima passed SubSystem Verification testing.
- IEC 60601 3rd ed.: Each applicable requirement from IEC 60601 3rd was treated as an acceptance criterion for the product and/or documentation. The full 3G system was tested, which includes the medical device hardware and optional/external mobile application and cloud server software. The scope of this testing was to perform all required medical device safety verification tests outlined in IEC 60601-1 and associated standards for 3G to ensure that it met all statutory requirements for electrical safety for medical devices sold in the US, Canada, the European Union and China. AcceleDent® Optima passed IEC 60601 3rd ed. testing.
- IEC 62133 Battery Safety: Each requirement from IEC 62133:2012 was treated as an acceptance criterion for the battery and/or documentation. This testing was conducted on the NiMH Cell Battery (17AAAH, 17AAAH1A6Z) to verify that it met all requirements of IEC 62133:2012. The CB Scheme test procedure included the following tests: charging procedure, continuous low-rate charging, vibration, temperature cycling, incorrect installation, external short circuit, free fall, mechanical shock (crash hazard), thermal abuse, crushing of the cells, low pressure, overcharge, and forced discharge. AcceleDent® Optima passed IEC 62133 Battery Safety testing.
- Packaging Distribution Testing: The following standards were used for testing: ASTM D 4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems, ASTM D 6198-12 Standard Guide for Transport Packaging Design, ASTM D3951-10 Standard for Commercial Packaging. The scope of this testing was to test the worse-case shipping scenario of 2 patient kit boxes shipped in an over-pack box, and a single parcel shipment of the RMA box, due to the fact that RMA boxes are not shipped in an overpack box. Two separate boxes were tested in this shipping scenario. AcceleDent® Optima passed Packaging Distribution testing.
- DEHP: The activator and mouthpiece could contain more than or equal to 0.1% by mass of DEHP as per design requirements. The purpose of the DEHP testing is to determine the amount of Diethylhexyl Phtalate (DEHP) present in the 3G mouthpiece and activator. AcceleDent® Optima passed DEHP testing.
- Latex Evaluation: Test was conducted for study purposed to substantiate the claim that the device is not intentionally manufactured with latex. The purpose of the latex testing was to ensure that the 3G device will not experience any biological adverse reactions due to the presence of latex. AcceleDent® Optima passed Latex testing.
- HFE-75 (Summative Testing): The following standards were utilized: ANSI/AAMI HE75:2009/(R):2013 Human factors engineering - Design of medical devices, ANSI/AAMI/IEC 62366:2007/(R)2013 & A1:2013 Medical Devices - Application of usability engineering to medical devices. The Summative Testing was performed to demonstrate that the final AcceleDent Optima System user interface can be used by the intended users safely and effectively for the intended use and under the expected use conditions. AcceleDent® Optima passed Summative testing.
- Bluetooth Certification: Bluetooth Radio Compliance was per Bluetooth SIG, which includes approval of BLE RF sub-system performance. The purpose of the Bluetooth Radio Compliance Testing is to test the AcceleDent 3G activator to achieve both Bluetooth SIG- BQE Certificate and Bluetooth SIG – RF Approval (Low Energy) Testing. AcceleDent® Optima passed Bluetooth Certification testing.
- FCC Compliance Testing: The FCC compliance testing is one of the required components of the IEC 60601 testing (within the EMC testing). Refer to the IEC 60601 3rded. Study criteria above. Federal Communications Commission (FCC) testing is a requirement for all electronic products that radiate unintentional emissions. Receiving the FCC Mark certification certifies that the electromagnetic interference is under the limits approved by the FCC. AcceleDent® Optima passed FCC Compliance testing.
- Physical Properties Testing for Mouthpiece: Hardness DIN ISO 7610, Density DIN EN ISO 1183-1, Tensile Strength DIN 53504/ISO 37, Elongation at Break DIN 53504/ISO 37, Tear Resistance ISO 34-1 Method B.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2017
OrthoAccel Technology Inc. Jouana Harris-Livings Director of Quality Assurance and Regulatory Affairs 6575 West Loop South, Suite 200 Bellaire, Texas 77401
Re: K170093
Trade/Device Name: AcceleDent® Optima Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: OYH Dated: April 20, 2017 Received: April 21, 2017
Dear Jouana Harris-Livings:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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,
Lori A. Wiggins -S6
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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Image /page/2/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The word "OrthoAccel" is written in a blue sans-serif font, with the first part of the word in a lighter shade of blue. The word "Technologies, Inc" is written in a smaller, gray sans-serif font below the first word. The logo is simple and modern, and it is likely used to represent the company's brand.
Modified AcceleDe 510(k) Premarket Notification
Indication for Use
510(k) Number (if known): K170093
Device Name: AcceleDent® Optima
Indication For Use:
AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Device Evaluation (ODE)
Division Sign-Off
510(k)
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Image /page/3/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue, and the word "Accel" is in gray. There are three curved lines to the left of the word "Ortho" that look like sound waves.
510(k) Summary - AcceleDent® Optima K170093
January 09, 2017 (updated May 26, 2017)
This summary of 510(k) substantial equivalence determination is being submitted in accordance with the requirements of 21 CFR part 807.92.
510(k) Submitter: OrthoAccel® Technologies, Inc. 6575 West Loop South, Suite 200 Bellaire, TX 77401 Phone: 832-803-0339 Fax: 713-583-9972
Contact: Jouana Harris-Livings
| Device trade name: | AcceleDent® Optima |
|---|---|
| Common name: | Orthodontic plastic bracket |
| Classification name: | Orthodontic plastic bracket |
| Regulation number: | 21 CFR 872.5470 |
| Classification: | Class II |
| Panel: | Dental |
| Product codes: | OYH |
| Product code names | Orthodontic vibratory accessory and orthodontic LED accessory |
| Predicate Device: | AcceleDent® Aura, 510(k) Number K153048 |
Indications for Use:
AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Device Description:
The AcceleDent® Optima is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Optima should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
This Premarket Notification (510(k)) is being submitted because the legally marketed OrthoAccel Technologies, Inc. device AcceleDent® Aura has been modified. Although the technological characteristics of the device and the indications for use described in our previous 510(k) K153048 remain unchanged, the design, raw material, manufacturing processes and related software have changed, resulting in the creation of the AcceleDent® Optima device.
Software:
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Image /page/4/Picture/0 description: The image shows the logo for OrthoAccel. The logo features the word "Ortho" in blue, with three curved lines above it, resembling sound waves. To the right of "Ortho" is "-Accel" in gray, with a small registered trademark symbol next to it. The logo is simple and modern, using a clean font and a two-tone color scheme.
The changes in software within the AcceleDent® Optima device allows for wireless transfer of data confirmed by Bluetooth and FCC testing, with a Moderate Level of Concern as determined by the risk assessment. The changes neither affect the mechanism of which the force is applied, nor the indications for use.
Material Characteristics:
Changes have been made to both the material of the activator and the mouthpiece for the AcceleDent® Optima, although they are both still Elastomers as used in the AcceleDent® Aura. Verification testing and risk evaluation has deemed these updated materials as low risk to the user.
Manufacturing Process:
There have been some changes made to the manufacturing processes in the AcceleDent® Optima device. Unlike AcceleDent® Aura, AcceleDent® Optima Activator is waterproof and thus requires ultrasonic welding to maintain the required IP rating. Additionally, assembly processes have been modified to accommodate the new design and the addition of the Charging Case. However, all major internal device components are relatively the same – PCB assembly, battery (although a NiMH rather than a lithium battery is used), and motor with off-set weight.
Performance Data Table:
The table below lists all performance testing performed on the AcceleDent® Optima to ensure its safety and efficacy.
| Test | Standards/Requirements |
|---|---|
| Biocompatibility | The biocompatibility testing consisted of the following tests: Cytotoxicity, |
| Intracutaneous Reactivity Irritation, Maximization Sensitization, and ISO/USP | |
| Acute System Toxicity. | |
| Reference ISO 10993-5:2009 (E) | |
| Reference ISO 10993-10:2010(E) | |
| Reference ISO 10993-10:2010(E) | |
| Description | The purpose of the biocompatibility testing was to verify that the users of the |
| AcceleDent 3G/Optima device will not experience any biological adverse | |
| reactions due to the product material, color, and manufacturing process. | |
| AcceleDent® Optima passed Biocompatibility testing. | |
| Bioburden | |
| Enumeration | Since this test was conducted for study purposes only, there was no identified |
| acceptance criteria. | |
| Description | The bioburden testing was performed on the 3G mouthpiece and activator to |
| determine the total number of viable microorganisms on the medical device. | |
| AcceleDent® Optima passed Bioburden Enumeration testing. | |
| System Verification | This testing verified that the full system requirements, which includes the |
| medical device hardware and optional/external mobile application and cloud | |
| server software, met the requirements serving as enhancements over Aura. | |
| Description | The scope of the testing is to verify that the 3G product met all of its system |
| requirements. The system is comprised of the Activator, Charging Case, Cloud | |
| App, Mobile App, and Web Portal. | |
| AcceleDent® Optima passed System Verification testing. | |
| Firmware Unit Test | |
| Verification | No standards were utilized in this testing. The design requirements for the |
| AcceleDent® Optima firmware was tested. | |
| Description | The purpose of this test was to verify the firmware requirement were met by |
| firmware design. | |
| AcceleDent® Optima passed Firmware Unit Verification testing. | |
| SubSystem Test | |
| Verification | This testing verified that the medical device hardware met the performance |
| requirements of Aura for therapeutic force delivery, battery charging, usage | |
| logging, and environmental operation without the interface of optional/external | |
| software (i.e. mobile application, cloud server). | |
| Description | The scope of this testing is to verify that the physical components of the 3G |
| AcceleDent System function as intended. Devices under Test (DUT) are the | |
| Activator and Charging Case Assembly, AC Power Wall Adapter, Cable | |
| AcceleDent® Optima passed SubSystem Verification testing. | |
| IEC 60601 3rd ed. | Each applicable requirement from IEC 60601 3rd was treated as an acceptance |
| criterion for the product and/or documentation. The full 3G system was tested, | |
| which includes the medical device hardware and optional/external mobile | |
| application and cloud server software | |
| Description | The scope of this testing was to perform all required medical device safety |
| verification tests outlined in IEC 60601-1 and associated standards for 3G to | |
| ensure that it met all statutory requirements for electrical safety for medical | |
| devices sold in the US, Canada, the European Union and China. | |
| AcceleDent® Optima passed IEC 60601 3rd ed. testing. | |
| IEC 62133 Battery | |
| Safety | Each requirement from IEC 62133:2012 was treated as an acceptance criterion |
| for the battery and/or documentation. | |
| Description | This testing was conducted on the NiMH Cell Battery (17AAAH, 17AAAH1A6Z) to |
| verify that it met all requirements of IEC 62133:2012. The CB Scheme test | |
| procedure included the following tests: charging procedure, continuous low- | |
| rate charging, vibration, temperature cycling, incorrect installation, external | |
| short circuit, free fall, mechanical shock (crash hazard), thermal abuse, crushing | |
| of the cells, low pressure, overcharge, and forced discharge. | |
| AcceleDent® Optima passed IEC 62133 Battery Safety testing. | |
| Packaging Distribution | |
| Testing | The following standards were used for testing: |
| ASTM D 4169-14 Standard Practice for Performance Testing of Shipping | |
| Containers and Systems | |
| ASTM D 6198-12 Standard Guide for Transport Packaging Design | |
| ASTM D3951-10 Standard for Commercial Packaging | |
| Description | The scope of this testing was to test the worse-case shipping scenario of 2 |
| patient kit boxes shipped in an over-pack box, and a single parcel shipment of | |
| the RMA box, due to the fact that RMA boxes are not shipped in an overpack | |
| box. Two separate boxes were tested in this shipping scenario. | |
| AcceleDent® Optima passed Packaging Distribution testing | |
| DEHP | The activator and mouthpiece could contain more than or equal to 0.1% by |
| mass of DEHP as per design requirements. | |
| Description | The purpose of the DEHP testing is to determine the amount of Diethylhexyl |
| Phtalate (DEHP) present in the 3G mouthpiece and activator. | |
| AcceleDent® Optima passed DEHP testing. | |
| Latex Evaluation | Test was conducted for study purposed to substantiate the claim that the |
| device is not intentionally manufactured with latex. | |
| Description | The purpose of the latex testing was to ensure that the 3G device will not |
| experience any biological adverse reactions due to the presence of latex. | |
| AcceleDent® Optima passed Latex testing. | |
| HFE-75 (Summative | |
| Testing) | The following standards were utilized: |
| ANSI/AAMI HE75:2009/(R):2013 Human factors engineering - Design of medical | |
| devices | |
| ANSI/AAMI/IEC 62366:2007/(R)2013 & A1:2013 Medical Devices - Application of | |
| usability engineering to medical devices | |
| Description | The Summative Testing was performed to demonstrate that the final |
| AcceleDent Optima System user interface can be used by the intended users | |
| safely and effectively for the intended use and under the expected use | |
| conditions. | |
| AcceleDent® Optima passed Summative testing. | |
| Bluetooth Certification | Bluetooth Radio Compliance was per Bluetooth SIG, which includes approval of |
| BLE RF sub-system performance. | |
| Description | The purpose of the Bluetooth Radio Compliance Testing is to test the |
| AcceleDent 3G activator to achieve both Bluetooth SIG- BQE Certificate and | |
| Bluetooth SIG – RF Approval (Low Energy) Testing. | |
| AcceleDent® Optima passed Bluetooth Certification testing. | |
| FCC Compliance | |
| Testing | The FCC compliance testing is one of the required components of the IEC 60601 |
| testing (within the EMC testing). Refer to the IEC 60601 3rded. Study criteria | |
| above. | |
| Description | Federal Communications Commission (FCC) testing is a requirement for all |
| electronic products that radiate unintentional emissions. Receiving the FCC | |
| Mark certification certifies that the electromagnetic interference is under the | |
| limits approved by the FCC. | |
| AcceleDent® Optima passed FCC Compliance testing. | |
| Physical Properties | |
| Testing for | |
| Mouthpiece | Hardness DIN ISO 7610 |
| Density DIN EN ISO 1183-1 | |
| Tensile Strength DIN 53504/ISO 37 | |
| Elongation at Break DIN 53504/ISO 37 | |
| Tear Resistance ISO 34-1 Method B |
AcceleDent® Optima: Traditional 510(k), (5) Page 3 of 6
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Image /page/5/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue and has three curved lines to the left of it, resembling sound waves. The word "Accel" is in gray and has a small registered trademark symbol to the right of it.
AcceleDent® Optima: Traditional 510(k), (5) Page 4 of 6
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Image /page/6/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue, and there are three curved lines to the left of the word. The word "Accel" is in gray, and there is a registered trademark symbol to the right of the word.
Substantial Equivalence Information:
This Premarket Notification is being submitted to demonstrate substantial equivalence of the AcceleDent® Optima to the existing AcceleDent Aura (K153048). The data within this submission exhibits that the indications for use and the technology used to produce the
AcceleDent® Optima: Traditional 510(k), (5) Page 5 of 6
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Image /page/7/Picture/0 description: The image shows the logo for OrthoAccel. The logo features the word "Ortho" in blue, followed by "-Accel" in gray. There are three curved lines above the word "Ortho" that resemble sound waves. The logo is simple and modern, and the colors are eye-catching.
0.25 N (25 grams) force level and 30 Hz frequency required to deliver the treatment are the same; thus, these two devices are substantially equivalent.
AcceleDent® Optima: Traditional 510(k), (5) Page 6 of 6