DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.

Device Description

DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DentureID.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient.

AI/ML Overview

This document describes the non-clinical performance testing of the DentureID Microchip.

1. Table of Acceptance Criteria and Reported Device Performance

Test Description	Standard	Acceptance Criteria (Implied by Result)	Reported Device Performance
Biocompatibility
Cytotoxicity	ISO 10993-5:2009	Non-cytotoxic (score '0')	The test article scored '0' at 24, 48, and 72 ± 4 hours and is considered non-cytotoxic under the conditions of this test.
Irritation	ISO 10993-10:2010	Mean test and control scores of extract dermal observations less than 1.0	The differences in the mean test and control scores of the extract dermal observations were less than 1.0, indicating that the requirements of the ISO Intracutaneous Reactivity Test have been met by the test article.
Sensitization	ISO 10993-10:2010	No sensitization response greater than '0' for test article extracts	None of the negative control animals challenged with the control vehicles were observed with a sensitization response greater than '0'. None of the animals challenged with the test article extracts were observed with a sensitization response greater than '0'. The normal saline extract of the test material had a sensitization response of '0' under valid test conditions. The sesame oil extract of the test material had a sensitization response of '0' under valid test conditions. Under the conditions of this protocol, the test article did not elicit a sensitization response.
Chemical Characterization of Materials (Leachate)	Proprietary standards of Nelson Laboratories and ChemTech Ford Laboratories	Potential toxicity from leaching of harmful chemicals is not significant	The incremental substances found in the study are presented and compared to toxicity standards for the respective materials. As a result of the study, we feel that the potential toxicity from leaching of harmful chemicals from the DentureID RFID tag is not significant.
Information Security Procedures	Not specified	Passed	Passed
Software Validation	Not specified	Passed	Passed
Migration Testing of Implanted Transponder	Not specified	Passed	Passed
Performance Testing of Implanted Transponder	Not specified	Passed	Passed
Electromagnetic Compatibility (EMC)
Radiated Emissions	EN 55011:2009	Pass	Pass
Electrostatic Discharge Immunity	EN 61000-4-2:2008	Pass	Pass
Radiated Electromagnetic Field Immunity	EN 61000-4-3:2010	Pass	Pass
Magnetic Field Immunity	EN 61000-4-8:2009	Pass	Pass
Data Integrity (during EMC)	Not specified	No loss or corruption of data, latency, or throughput	No loss or corruption of the data, latency or through-put, which was coordinated with the electromagnetic compatibility (EMC) performance of the microchip, scanner and wireless data link.
Magnetic Resonance Imaging Compatibility (MRI)
Magnetic Field Interactions at 3-Tesla	ASTM F2052-15	No additional risk or hazard to a patient in the 3-Tesla MRI environment or less with regard to torque (qualitative measurement of 0)	The qualitatively measured torque at 3-Tesla for the DentureID was 0, no torque. As such, this device will not present an additional risk or hazard to a patient in the 3-Tesla MRI environment or less with regard to torque.
MRI-related heating, 1.5-Tesla and 3-Tesla	ASTM F2182-11a	Maximum temperature rise matches background (e.g., 1.5°C at 1.5T, 1.9°C at 3T)	1.5-Tesla demonstrated a maximum of 1.5°C temperature rise and the 3-T system demonstrated a 1.9°C rise. Both of these temperature rises matched the maximum background temperature rise. In conclusion, MRI 1.5 and 3 do not induce significant heating to DentureID Microchip.
Artifacts at 3-Tesla	ASTM F2119-07 (Reapproved 2013)	Localized signal voids corresponding to device size and shape; maximum artifact size around 10-mm relative to device size.	The artifacts that appeared on the MR images were shown as localized signal voids (i.e., signal loss) that corresponded to the size and shape of this device. The gradient echo pulse sequence produced larger artifacts than the T1-weighted, spin echo pulse sequence for the device. The maximum artifact size (i.e., as seen on the gradient echo pulse sequence) extends approximately 10-mm relative to the size and shape of this device.
Effects of MRI at 1.5-Tesla and 3-Tesla on Function	Not specified (Internal investigation protocol)	100% pre and post-exposure performance	DentureID Microchips performed 100% pre and post exposures.
Simulated Wear (Denture Cleaning)	Not specified (Internal protocol based on 5-year simulated wear with cleaning medium/brush)	No impact on device performance; clear self-cure dental acrylic not affected	The clear self-cure dental acrylic placed over the DentureID Microchip was not affected by the scrubbing action. Therefore, cleaning dentures will not impact the performance of DentureID Microchip.

Study Information:

The provided document describes non-clinical performance testing to demonstrate the substantial equivalence of the DentureID Microchip to its predicate devices. It does not detail a clinical study involving human readers or a training set in the context of typical AI device evaluation.

Here's a breakdown of the available information:

2. Sample Sizes and Data Provenance for Test Set:

Cytotoxicity, Irritation, Sensitization: These tests involve biological samples (e.g., cell cultures, animals). The document doesn't specify the exact number of samples/animals used but refers to the standards (ISO 10993-5, ISO 10993-10) which define such sample sizes. The data provenance is implied to be laboratory testing in facilities adhering to these standards, likely in the US given the FDA submission. These are retrospective tests conducted on device materials.
Chemical Characterization: Not specified, but involved proprietary standards of Nelson Laboratories and ChemTech Ford Laboratories. Retrospective laboratory testing.
EMC Testing: Not specified for the number of devices tested, but it's laboratory testing of the DentureID Microchips. Retrospective.
MRI Compatibility: Not specified for the number of devices tested, but it's laboratory testing of DentureID Microchips to ASTM standards. Retrospective.
Simulated Wear: Not specified for the number of DentureID Microchips installed in dentures, but it's a non-clinical performance test over a 5-year simulation. Retrospective.

3. Number of Experts and their Qualifications for Ground Truth:

This information is not applicable in the context of this non-clinical performance testing. The "ground truth" for these tests is established by adhering to recognized international standards (ISO, ASTM, EN) and laboratory protocols, with results interpreted by qualified laboratory personnel (e.g., toxicologists, engineers) who execute these specific tests.

4. Adjudication Method for the Test Set:

Not applicable. These are objective, quantitative and qualitative laboratory tests against defined scientific and engineering standards, not subjective interpretations requiring adjudication by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was NOT done. This document focuses on the technical and safety performance of the device itself (hardware and its interaction with a smartphone app), not on the diagnostic or interpretative ability of human readers or AI in a clinical setting. Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Yes, in essence, standalone performance testing was done for the core function of the microchip. The various tests (Biocompatibility, EMC, MRI Compatibility, Simulated Wear, Migration Testing, Performance Testing of Implanted Transponder) evaluate the physical and functional characteristics of the DentureID Microchip itself, independent of a human interpreting its output. The "algorithm" here is the RFID chip's ability to respond with its serial number and the smartphone app's ability to retrieve information from a database. "Performance Testing of Implanted Transponder" is a direct measure of this standalone function.

7. Type of Ground Truth Used:

The ground truth for this non-clinical testing is based on:
- Standardized test methods and protocols: Defined by international standards (ISO, ASTM, EN) and proprietary laboratory standards.
- Objective measurements and observations: E.g., cytotoxicity scores, temperature rises, torque measurements, pass/fail criteria for EMC.
- Chemical analysis: For leachate testing.

8. Sample Size for the Training Set:

Not applicable. This device (DentureID Microchip) is a passive RFID transponder and its associated database/app. It does not employ machine learning or AI models that require a "training set" in the conventional sense for image analysis or diagnostic tasks. Its function is to communicate a serial number, which then links to pre-entered data on a website.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model for this device. The information stored on the DentureID.com website, which is retrieved by the microchip's serial number, is entered by a dental lab or dentist. This user-provided information serves as the "ground truth" for the data it's designed to return, but it's not a training set for an algorithm.

Summary

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October 25, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CMP Industries LLC Devon Howe President and CEO 413 N. Pearl St. Albany, New York 12207

Re: K170423

Trade/Device Name: DentureID Microchip Regulation Number: 21 CFR 880.6300 Regulation Name: Implantable Radiofrequency Transponder System For Patient Identification And Health Information Regulatory Class: Class II Product Code: PYQ, OUG Dated: August 8, 2017 Received: August 10, 2017

Dear Devon Howe:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,

Mary S. Runner -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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Image /page/2/Picture/0 description: The image is the logo for Nobilium, a company that specializes in prosthetic dentistry. The logo features a blue emblem on the left, followed by the word "NOBILIUM" in large, blue, bold letters. Below the company name is the tagline "Your Partner In Prosthetic Dentistry" in a smaller, blue font.

Division of CMP Industries LLC

413 North Pearl Street Albany, New York, 12207-1311 · USA 800 833-2343 · 518 434-3147 · Fax: 518 434-1288 USA Email: info@nobilum.com Export Email: export@nobilium.com Website: www.nobilium.com ISO 13485:2003

510(k) Summary for DentureID Microchip K170423/S001

1. Applicant

Submitter's Name: Devon Howe

Date Summary Prepared: Revised August 7, 2017

Address: CMP Industries LLC 413 N. Pearl St. Albany, NY 12207
Phone: 518-434-3147 ext 128

Email: howed@nobilium.com

Fax: 518-434-1288

2. Device Name

Proprietary Name: DentureID Microchip

Common Name: RFID Tag ISO 14443 micro-transponder embedded into medical grade epoxv

Classification Name: Implantable Radiofrequency Transponder System for Patient Identification and Health Information (21 CFR 880.6300) Product Code: PYQ Device Class: 2 (special controls)

3. Predicate Devices

Primary: VeriChip implantable radio frequency transponder system (DEN040007) by VeriChip Corporation (now called PositiveID) and purchased by Jamm Technologies

Common Name: RFID Tag ISO 11784/85 micro-transponder o
Classification Name: Implantable Radiofrequency Transponder System for O Patient Identification and Health Information (21 CFR 880.6300)
Product Code: NRV O
Device Class: 2 (special controls) с

Reference: SMARTSPONGE SYSTEM (K071355) by ClearCount Medical Solutions, Inc. now marketed by Medline Industries, Inc.

Common Name: RFID Tag ISO 15693 micro-transponder embedded into O medical grade epoxy and sewn into surgical sponge
Classification Name: Surgical sponge scale (21 CFR 880.2740) O
Product Code: LWH O

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o Device Class: 1

4. Device Description

A. Overview: DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. Denture identification is required by many US state governments because dentures are frequently lost. DentureID.com complies with these regulations by discreetly using a microchip instead of a visible patient name. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a

repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. This information could be important to identify and contact the owner if a

Image /page/3/Picture/4 description: The image shows a close-up of a denture with a small, round sticker on it. The sticker has the text "DENTURE ID.COM" printed around the edge of the circle. In the center of the sticker, there is a small, dark square, possibly a QR code or some other type of identification mark. The denture itself is made of a pinkish material, and some of the teeth are visible at the bottom of the frame.

DentureID Microchip placed on the buccal flange of a denture

denture is found. Also, if a denture requires repair, this information will be extremely valuable to a dentist or denturist who must match the size and color of denture teeth, denture base or implant/attachment components. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DenturelD.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip.

The DentureID Microchip is not a tracking system so it will not help in finding a lost denture. It is passive and does not emit any signal until powered by a compatible Smart Phone using NFC (near field communication).

B. Explanation of How the Device Functions: DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. A password is not required to read the microchip, however, intimate contact between the smart phone and the microchip is required. The NFC-compliant smart phone emits a low level of energy which "activates" the DenturelD Microchip when placed within intimate contact. The DentureID Microchip responds to the SmartPhone with its serial number. The SmartPhone then requests the information associated with the microchip serial number stored on the DentureID website. The website returns the stored information and displays it on the SmartPhone. Because there is no significant patient risk if the App malfunctions, this App is not considered a "Mobile Medical App."

DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flanqe of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient. The process to insert the microchip into a denture is performed with lower labor cost as compared to conventional denture identification methods, and it satisfies denture identification regulations required in 27 US States and federal facilities. Information associated with the unique identification code of the microchip is entered by a dental lab or

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dentist on the DentureID.com website. This information will appear on a SmartPhone when using the DentureID.com app and holding the SmartPhone directly on the DentureID.com microchip.

The patient contact information retrieved from DentureID will greatly assist care givers to locate owners of lost dentures. In addition, information from DentureID Microchips will greatly help a dentist to identify elements of a denture in the case of repair. These elements may include: the type and color of denture base, teeth size and color, clips, attachment housings and implant components. These elements are nearly impossible to identify otherwise, so DentureID Microchips will improve the quality of patient care.

In the event that a denture is placed in view of others who are not "covered entities" under HIPAA regulations, DentureID Microchips help to improve caregiver compliance with privacy requlations because the denture patient's name is not visible, unlike conventional denture identification methods.

C. Scientific Concepts That Form the Basis For The Device: The DentureID Microchip does not hold an electric charge. It remains inactive until energized by an NFC reader using RFID ISO 14443 (a common standard used at 13.56Mhz) that makes intimate contact. The low level of energy emitted by the reader (smart phone in NFC mode) "wakes-up" the microchip which responds with a unique serial number. The reader (smart phone) then communicates the serial number to the DentureID.com database and the database responds with information to display on the reader (smart phone).

D. Significant Physical and Performance Characteristics

i. Device Design - The device design is a standard RFID ISO 14443 which enables NFC communication at very short (< 1cm) distances.

ii. Material Used - The microchip is not powered and does not emit any radiation. The following is a list of materials and components used to make DentureID Microchips:

Microchip: Chip #NTAG213 — Manufactured by NXP. This chip is RFID ISO 14443 standard that uses NFC (near-field communication). 2) Very thin copper wire 3) Clear film printed with the words "DENTUREID.COM" 4) Medical-Grade Epoxy: LOCTITE® M-31CL™

iii. Physical Properties - The DentureID Microchip emits no energy. It responds to a 13.56Mhz transponder (smart phone and other readers) which emits approximately 40 microwatts (10-6 watts). According to the physical properties data sheet for the LOCTITE M-31CL (primary contents by mass), the Physical Properties are as follows:

Image /page/4/Picture/9 description: The image shows a small, round object with the words "Denture ID.co" printed on it. There is a small, dark square in the center of the object. The object appears to be made of clear plastic with a copper coil around the edge. The words are printed in black ink.

Glass Transition Temperature, ASTM E 228, °C 70 Elongation, ASTM D 638, % 8 Tensile Strength, ASTM D 638 N/mm² 55.2 (psi) (8,000)

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E. Duration and Type of Contact: DentureID Microchip does not contact the patient. It is embedded into a denture and completely covered with self-cure PMMA repair resin. Dentures are rarely worn 24-hours per day. They mostly removed during sleep.

F. User Procedure: The current standard of care for denture fabrication begins with a dental professional (dentist, denturist, prosthodontist) providing an impression or model and information about the case, generally including the patient's name, to a dental laboratory. The dental professional and dental laboratory are currently bound by confidentiality requlations and are "covered entities" as defined by HIPAA. When using a DentureID Microchip, the dental laboratory will fabricate the denture, insert the DentureID Microchip (dental laboratory technicians are generally familiar with denture base acrylics) and enter key information about the denture, including patient name (if provided by the dental professional), into a secure server which requires a username and password. After data entry, the dental laboratory will verify the information was entered correctly by reading the DentureID Microchip with a reader (smart phone).

The dental laboratory keeps one of the 3-part adhesive labels and adheres it to their documentation about the case which they presently safeguard per HIPAA regulations. The lab sends the other two adhesive labels with the dental prosthetic appliance to the dental professional. The dentist will keep one label with the clinical documentation on the case and give the other adhesive label to the patient. The dentist copy has space for the patient to sign and acknowledge that they are consenting to place information on DentureID.com website (consent is required part of HIPAA1). The dental professional, laboratory or patient may edit or remove information stored on the DentureID website. If the username or password is lost, the dentist and dental laboratory will have a record of the username and password. See section 13, Proposed Labeling, for more information and Directions for Use.

G. Model Numbers: The model number D1EN is the English version with denture branding. Future models will be other languages and branding for other appliances such as mouthguards and retainers.

H. Software - Reader: The person reading the DentureID Microchip embedded into a denture will likely use a smart phone such as an Android capable of NFC communication. The user must first download the DentureID app for Android smart phone from the Google Play store. Apple has NFC on their most modern phones for use with proprietary Apple systems such as ApplePay. Apple is planning to release NFC on their phones to developers for new applications, such as DentureID Microchip.

I. Software - Web Server: Data about the denture is entered into and maintained by a secure server hosted by Amazon. There are many healthcare organization who use the same services, including The Centers for Medicare and Medicaid Services (CMS). Details about the web server:

Operating System: Windows server 2008 R2 ।
Database: Microsoft SQL Server 2008 R2 Web edition ।
Web Server: Internet Information Service 7 ।
The SQL database access is restricted through credentials -
-We will purchase an SSL certificate associated with www.dentureid.com domain so

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that the web app can be accessed over https instead of normal http. This will ensure the data is encrypted over the network.

J. Disease Conditions (Devices): The DentureID Microchip will assist dentists to treat patients who are:

1. Edentulous (Complete Dentures)
1. Partially Edentulous (Partial Dentures)
1. Bruxing (Night Guards)
1. Protecting Teeth During Contact Activity (Sports Guard)
1. Involved with Teeth or Jaw Alignment Therapy (Retainer, Alignment Tray)

5. Intended Use

Indication for Use: DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances.

General Description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate: Edentulism (people with missing teeth) and people who wear removable dental appliances

Description of the patient population for which the device is intended:

Primary: Full or partially edentulous patients.

Secondary: Patients who wear bruxing (night guard) appliances and other removable appliances such as a Sports Guards, Retainers and Alignment Trays, etc.

DentureIDMicrochip(K170423)	VeriChip(DEN040007)Predicate (Primary)	SmartSponge(K071355) Predicate(Reference)	Comments
DentureID Microchipis intended toenable access tosecure patientidentification anddevice informationwhen used withcomplete dentures,partial dentures andother removable oralappliances	The VeriChip is indicatedfor use as a miniature,implantable microchipthat is inserted into thesubcutaneous tissue ofthe patient. TheVeriChip provides thepatient a uniqueidentification numberthat may be used toaccess a databasecontaining the patient'sidentity and healthinformation.	The ClearCountMedical SolutionsSmartSpongeTMSystem isindicated for use incounting andrecording the numberof RFID taggedsurgical sponges,laparatomy spongesand towels usedduring surgicalprocedures.	The output portion ofthe indications for usefor VeriChip is virtuallyidentical to DentureIDMicrochip because bothchips respond with aunique identificationnumber correspondingto a patient.

6. Indication Statements Comparison

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7. Technological Characteristics and Substantial Equivalence

	DentureID MicrochipMicro-TransponderSpecifications	VeriChipPredicate (Primary)Micro-TransponderSpecifications	SmartSpongePredicate (Reference)Micro-TransponderSpecifications
CommonName	RFID Tag ISO 14443micro-transponderembedded into medicalgrade epoxy	RFID Tag ISO 11784/85micro-transponder	RFID Tag ISO 15693micro-transponderembedded into medicalgrade epoxy and sewninto surgical sponge
FDAClassificationNumber	ImplantableRadiofrequencyTransponder System forPatient Identification andHealth Information (21CFR 880.6300)	ImplantableRadiofrequencyTransponder System forPatient Identification andHealth Information (21CFR 880.6300)	Surgical sponge scale(21 CFR 880.2740)
510(k)Number	K170423	DEN040007	K071355
OperatingFrequency	13.56Mhz	134.2 kHz ± 3 kHz	13.56Mhz
Peak High Op.Temperature	Up to +85° C (+185° F)	Up to +180° C (+356° F)	Up to +125° C (+257° F)
ElectricalCharacteristics	Passive - Operateswhen in presence ofcompatible SmartPhonein NFC mode	Passive - Operates whenin presence of VeriChip's"Pocket Reader"	Passive - Operateswhen in presence ofcompatible reader
FunctionalPerformance	Read Range potential upto 50mm, but max is5mm (≈ 0.5 in) as testedin DentureID applicationsusing Android SmartPhone.	Read Range 63.5mm (≈3.0 in)	Read Range potential upto 1 to 1.5 meters (19 into 59 in)
WriteProtected	Yes	Yes	Yes
Self-Powered	No	No	No
EncapsulatingMaterial	LOCTITE M-31CLMedical Grade Epoxy	None	LOCTITE M-31CLMedical Grade Epoxy
TrackingDevice	No	No	No
Compatibility	Compatible with variouspolymers and materials	Compatible with variouspolymers and materials	Compatible with variouspolymers and materials
PatientContact	Encapsulated Microchipand epoxy shell do nottouch human tissue	Encapsulated Microchipdoes not touch patient,but outer shell does	Encapsulated Microchipdoes not touch patient,but epoxy shell may
AnatomicalSite	Mouth	Subcutaneous	Intra-abdominal

Source of data from company literature and manufacturer of RFID micro-transponders.

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Similarities between DentureID Microchip and VeriChip (Primary Predicate)

The indications for use for DentureID Microchip are virtually the same as the Primary ● Predicate because both are RFID micro-transponders and thev both respond with a unique identification number corresponding to a patient.
Both micro-transponders are passive and require energy from an outside source to . respond with a serial number.
o Both micro-transponders are not tracking devices and are write-protected

Similarities between DentureID and SmartSponge (Reference Predicate)

Both are RFID micro-transponders and they both respond with a unique identification number.
Both RFID micro-transponders are embedded into LOCTITE M-31CL Medical Grade ● Ероху.

Differences between DentureID Microchip and VeriChip (Primary Predicate)

The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because VeriChip is designed to be read from a further distance because it is under the skin and the exact location may be unknown. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. Because DentureID Microchip requires close proximity read (<1 cm), it nearly impossible for an unauthorized person to obtain information related to the denture. This feature makes information from DentureID Microchip more secure than VeriChip.
The DentureID micro-transponder and epoxy encapsulating material do not touch the patient because the DFU requires covering the device with dental acrylic. However. the VeriChip encapsulated micro-transponder is located subcutaneously. This difference does not raise any substantial equivalence concerns because DenturelD is not invasive by design and results in lower patient risk.

Differences between DentureID and SmartSponge (Reference Predicate)

The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because SmartSponge is designed to be read from a further distance because they could be located in the abdomen and the exact location may be unknown or they could be located in the "out scanner bucket" grouped together. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read.

Applicable Standards

10993-1; Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process
ISO 1993-5; ISO MEM Elution Using L929, Mouse Fibroblast Cell (GLP) Cytotoxicity (2009)
ISO 1993-10; Biological Evaluation Of Medical Devices Part 10: Tests For Irritation ● And Skin Sensitization
ISO 7405 Evaluation of biocompatibility of medical devices used in dentistry ●
IEC 60601-1-2 International Medical Safety Standard 2014 ●
o F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force of Medical Devices in the Magnetic Resonance Environment 2015

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8. Non-Clinical Performance testing and Compliance

The following non-clinical tests were conducted to evaluate the functionality, performance, safety and substantial equivalence as suggested by FDA's guidance for industry and FDA staff titled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information" issued on December 10, 2004.

A. BIOCOMPATIBILITYDescription	Standard	Result
Cytotoxicity	ISO 10993-5:2009Biological Evaluation ofMedical Devices, Part 5:Tests for In VitroCytotoxicity	The test article scored '0'at 24, 48, and 72 ± 4hours and is considerednon-cytotoxic under theconditions of this test.
Irritation	SO 10993-10: 2010Standard, BiologicalEvaluation of MedicalDevices, Part 10: Testsfor Irritation and SkinSensitization	The differences in themean test and controlscores of the extractdermal observations wereless than 1.0, indicatingthat the requirementsof the ISO IntracutaneousReactivity Test have beenmet by the test article.
Sensitization	The study was conductedin accordance with ISO10993-10:2010. BiologicalEvaluation of MedicalDevices, Part 10: Testsfor Irritation and SkinSensitization, pp. 18-26	None of the negativecontrol animals challengedwith the control vehicleswere observed with asensitization responsegreater than '0'. None ofthe animals challengedwith the test articleextracts were observedwith a sensitizationresponse greater than '0'.The normal saline extractof the test material had asensitization response of'0' under valid testconditions. The sesame oilextract of the test materialhad a sensitizationresponse of '0' under validtest conditions. Under theconditions of this protocol,the test article did not elicita sensitization response.
Chemical Characterizationof Materials (Leachate)	Proprietary standards ofNelson Laboratories and	The incrementalsubstances found in the
	ChemTech FordLaboratories	study are presented andcompared to toxicitystandards for therespective materials. As aresult of the study, we feelthat the potential toxicityfrom leaching of harmfulchemicals from the
		DentureID RFID tag is notsignificant.

A BIOCOMPATIBILITY

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B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION) -Passed

C. SOFTWARE VALIDATION - Passed

D. MIGRATION TESTING OF IMPLANTED TRANSPONDER - Passed

E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER - Passed

F. PERFORMANCE TESTING OF INSERTER - No inserter used

G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC

SCANNER - Responsibility of SmartPhone manufacturer

H. ELECTROMAGNETIC COMPATIBILITY

The following tests were completed on DentureID Microchips:

Description	Standard	Result
Radiated Emissions	EN 55011:2009	Pass
Electrostatic DischargeImmunity	EN 61000-4-2:2008	Pass
Radiated ElectromagneticField Immunity	EN 61000-4-3:2010	Pass
Magnetic Field Immunity	EN 61000-4-8:2009	Pass

In addition, the testing found no loss or corruption of the data, latency or through-put, which was coordinated with the electromagnetic compatibility (EMC) performance of the microchip, scanner and wireless data link.

I. ELECTRICAL SAFETY PERFORMANCE TESTING - The DentureID Microchip does not emit any energy, so safety performance testing is not required.

J. STERILITY - Device is not sterile

K. MAGNETIC RESONANCE IMAGING COMPATIBILITY

The following tests were completed on DentureID Microchips:

Description	Standard	Result
Magnetic Field Interactionsat 3-Tesla	(ASTM) Designation:F2052-15. StandardTest Method forMeasurement ofMagnetically InducedDisplacement Force onMedical Devices in theMagnetic ResonanceEnvironment.	The qualitativelymeasured torque at 3-Tesla for the DentureIDwas 0, no torque. Assuch, this device will notpresent an additional riskor hazard to a patient inthe 3-Tesla MRIenvironment or less with
		regard to torque.
MRI-related heating, 1.5-Tesla and 3-Tesla	ASTM Internationaldocument: AmericanSociety for Testing andMaterials International,Designation F2182–11aStandard Test Method forMeasurement of RadioFrequency InducedHeating On or NearPassive Implants DuringMagnetic ResonanceImaging	1.5-Tesla demonstrated amaximum of 1.5°Ctemperature rise and the3-T system demonstrateda 1.9°C rise. Both ofthese temperature risesmatched the maximumbackground temperaturerise. In conclusion, MRI1.5 and 3 do not inducesignificant heating toDentureID Microchip
Artifacts at 3-Tesla	(ASTM) InternationalDesignation: F2119-07(Reapproved 2013),Standard Test Method forEvaluation of MR ImageArtifacts from PassiveImplants	The artifacts thatappeared on the MRimages were shown aslocalized signal voids(i.e., signal loss) thatcorresponded to the sizeand shape of this device.The gradient echo pulsesequence producedlarger artifacts than theT1-weighted, spin echopulse sequence for thedevice. The maximumartifact size (i.e., as seenon the gradient echopulse sequence) extendsapproximately 10-mmrelative to the size andshape of this device.
Evaluation of the Effects ofMRI at 1.5-Tesla and 3-Tesla on the Function ofDentureID Microchip	The goal of thisinvestigation was todetermine the effects ofexposing the samples ofthe DentureID Microchipsto 1.5-Tesla/64-MHz and3-Tesla MRI conditionsand pulse sequencesselected to berepresentative of typicalclinical MRI techniques inorder to determine if thesedevices were damaged orif there was a change infunction.	DentureID Microchipsperformed 100% pre andpost exposures.

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ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: This standard has been addressed in Section 16.

ISO 7405 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry: This standard has been addressed in Section 16.

An additional non-clinical performance test was performed outside of the FDA Guidance Document. DentureID Microchips installed in dentures per DFU were subject to 5year simulated wear with a denture cleaning medium and denture brush. The results indicated that the clear self-cure dental acrylic placed over the DentureID Microchip was not affected by the scrubbing action. Therefore, cleaning dentures will not impact the performance of DentureID Microchip.

9. Conclusions

The DentureID Microchip is substantially equivalent to VeriChip because the technology is functionally the same and the output portion of the indications for use for VeriChip is virtually identical to DentureID Microchip. Benchtop testing proved compliance with FDA's guidance for industry and FDA staff. Because DentureID is not inserted into patients, DentureID Microchip presents significantly less patient risk than VeriChip. DentureID Microchip is more effective and performs better than the predicate device, VeriChip, because:

DentureID Microchip does not require a specialized reader
After reading a Denture ID Microchip, the information returned to the reader is robust and detailed compared to VeriChip which returns only two rows of 15 character alphanumeric strings.

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Image /page/13/Picture/0 description: The image shows the logo for Nobilium, a company that specializes in prosthetic dentistry. The logo features a blue emblem with a stylized face and crown, followed by the word "NOBILIUM" in bold, blue letters. Below the company name is the tagline "Your Partner In Prosthetic Dentistry" in a smaller, blue font.

Division of CMP Industries LLC

510(k) Summary for DentureID Microchip K170423/S001

1. Applicant

Submitter's Name: Devon Howe

Date Summary Prepared: Revised August 7, 2017

Address: CMP Industries LLC 413 N. Pearl St. Albany, NY 12207
Phone: 518-434-3147 ext 128

Email: howed@nobilium.com

Fax: 518-434-1288

2. Device Name

Proprietary Name: DentureID Microchip

Common Name: RFID Tag ISO 14443 micro-transponder embedded into medical grade epoxv

Classification Name: Implantable Radiofrequency Transponder System for Patient Identification and Health Information (21 CFR 880.6300) Product Code: PYQ Device Class: 2 (special controls)

3. Predicate Devices

Primary: VeriChip implantable radio frequency transponder system (DEN040007) by VeriChip Corporation (now called PositiveID) and purchased by Jamm Technologies

Common Name: RFID Tag ISO 11784/85 micro-transponder O
Classification Name: Implantable Radiofrequency Transponder System for O Patient Identification and Health Information (21 CFR 880.6300)
Product Code: NRV o
Device Class: 2 (special controls) o

Reference: SMARTSPONGE SYSTEM (K071355) by ClearCount Medical Solutions, Inc. now marketed by Medline Industries, Inc.

Common Name: RFID Tag ISO 15693 micro-transponder embedded into O medical grade epoxy and sewn into surgical sponge
Classification Name: Surgical sponge scale (21 CFR 880.2740) O
Product Code: LWH O

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o Device Class: 1

4. Device Description

Image /page/14/Picture/4 description: The image shows a close-up of a denture. The denture is made of a pink material and has white teeth. There is a small, round sticker on the denture that says "DENTURE ID.COM" in black letters. The sticker also has a small black square in the center.

DentureID Microchip placed on the buccal flange of a denture

B. Explanation of How the Device Functions: DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. A password is not required to read the microchip, however, intimate contact between the smart phone and the microchip is required. The NFC-compliant smart phone emits a low level of energy which "activates" the DentureID Microchip when placed within intimate contact. The DentureID Microchip responds to the SmartPhone with its serial number. The SmartPhone then requests the information associated with the microchip serial number stored on the DenturelD website. The website returns the stored information and displays it on the SmartPhone. Because there is no significant patient risk if the App malfunctions, this App is not considered a "Mobile Medical App."

DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient. The process to insert the microchip into a denture is performed with lower labor cost as compared to conventional denture identification methods, and it satisfies denture identification requlations required in 27 US States and federal facilities. Information associated with the unique identification code of the microchip is entered by a dental lab or

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dentist on the DentureID.com website. This information will appear on a SmartPhone when using the DentureID.com app and holding the SmartPhone directly on the DentureID.com microchip.

In the event that a denture is placed in view of others who are not "covered entities" under HIPAA requlations, DentureID Microchips help to improve caregiver compliance with privacy requlations because the denture patient's name is not visible, unlike conventional denture identification methods.

D. Significant Physical and Performance Characteristics

i. Device Design – The device design is a standard RFID ISO 14443 which enables NFC communication at very short (< 1cm) distances.

ii. Material Used - The microchip is not powered and does not emit any radiation. The following is a list of materials and components used to make DentureID Microchips:

Microchip: Chip #NTAG213 – Manufactured by NXP. This chip is RFID ISO 14443 standard that uses NFC (near-field communication). 2) Very thin copper wire 3) Clear film printed with the words "DENTUREID.COM" 4) Medical-Grade Epoxy: LOCTITE® M-31CL™

Image /page/15/Picture/9 description: The image shows a small, round, clear object with the words "Denture ID.CO WO" printed around the edge. There is a small, dark square in the center of the object. The object appears to be made of plastic or glass and has a smooth, shiny surface. The text is printed in black and is slightly blurred.

Glass Transition Temperature, ASTM E 228, °C 70 Elongation, ASTM D 638, % 8 Tensile Strength, ASTM D 638 N/mm² 55.2 (psi) (8,000)

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G. Model Numbers: The model number D1EN is the English version with denture branding. Future models will be other languages and branding for other appliances such as mouthguards and retainers.

Operating System: Windows server 2008 R2 ।
. Database: Microsoft SQL Server 2008 R2 Web edition
Web Server: Internet Information Service 7 .
The SQL database access is restricted through credentials -
-We will purchase an SSL certificate associated with www.dentureid.com domain so

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that the web app can be accessed over https instead of normal http. This will ensure the data is encrypted over the network.

J. Disease Conditions (Devices): The DentureID Microchip will assist dentists to treat patients who are:

1. Edentulous (Complete Dentures)
1. Partially Edentulous (Partial Dentures)
1. Bruxing (Night Guards)
1. Protecting Teeth During Contact Activity (Sports Guard)
1. Involved with Teeth or Jaw Alignment Therapy (Retainer, Alignment Tray)

5. Intended Use

Description of the patient population for which the device is intended:

Primary: Full or partially edentulous patients.

Secondary: Patients who wear bruxing (night guard) appliances and other removable appliances such as a Sports Guards, Retainers and Alignment Trays, etc.

DentureIDMicrochip(K170423)	VeriChip(DEN040007)Predicate (Primary)	SmartSponge(K071355) Predicate(Reference)	Comments
DentureID Microchipis intended toenable access tosecure patientidentification anddevice informationwhen used withcomplete dentures,partial dentures andother removable oralappliances	The VeriChip is indicatedfor use as a miniature,implantable microchipthat is inserted into thesubcutaneous tissue ofthe patient. TheVeriChip provides thepatient a uniqueidentification numberthat may be used toaccess a databasecontaining the patient'sidentity and healthinformation.	The ClearCountMedical SolutionsSmartSpongeTMSystem isindicated for use incounting andrecording the numberof RFID taggedsurgical sponges,laparatomy spongesand towels usedduring surgicalprocedures.	The output portion ofthe indications for usefor VeriChip is virtuallyidentical to DentureIDMicrochip because bothchips respond with aunique identificationnumber correspondingto a patient.

6. Indication Statements Comparison

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7. Technological Characteristics and Substantial Equivalence

	DenturelD MicrochipMicro-TransponderSpecifications	VeriChipPredicate (Primary)Micro-TransponderSpecifications	SmartSpongePredicate (Reference)Micro-TransponderSpecifications
CommonName	RFID Tag ISO 14443micro-transponderembedded into medicalgrade epoxy	RFID Tag ISO 11784/85micro-transponder	RFID Tag ISO 15693micro-transponderembedded into medicalgrade epoxy and sewninto surgical sponge
FDAClassificationNumber	ImplantableRadiofrequencyTransponder System forPatient Identification andHealth Information (21CFR 880.6300)	ImplantableRadiofrequencyTransponder System forPatient Identification andHealth Information (21CFR 880.6300)	Surgical sponge scale(21 CFR 880.2740)
510(k)Number	K170423	DEN040007	K071355
OperatingFrequency	13.56Mhz	134.2 kHz ± 3 kHz	13.56Mhz
Peak High Op.Temperature	Up to +85° C (+185° F)	Up to +180° C (+356° F)	Up to +125° C (+257° F)
ElectricalCharacteristics	Passive - Operateswhen in presence ofcompatible SmartPhonein NFC mode	Passive - Operates whenin presence of VeriChip's"Pocket Reader"	Passive - Operateswhen in presence ofcompatible reader
FunctionalPerformance	Read Range potential upto 50mm, but max is5mm (≈ 0.5 in) as testedin DentureID applicationsusing Android SmartPhone.	Read Range 63.5mm (≈3.0 in)	Read Range potential upto 1 to 1.5 meters (19 into 59 in)
WriteProtected	Yes	Yes	Yes
Self-Powered	No	No	No
EncapsulatingMaterial	LOCTITE M-31CLMedical Grade Epoxy	None	LOCTITE M-31CLMedical Grade Epoxy
TrackingDevice	No	No	No
Compatibility	Compatible with variouspolymers and materials	Compatible with variouspolymers and materials	Compatible with variouspolymers and materials
PatientContact	Encapsulated Microchipand epoxy shell do nottouch human tissue	Encapsulated Microchipdoes not touch patient,but outer shell does	Encapsulated Microchipdoes not touch patient,but epoxy shell may
AnatomicalSite	Mouth	Subcutaneous	Intra-abdominal

Source of data from company literature and manufacturer of RFID micro-transponders.

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Similarities between DentureID Microchip and VeriChip (Primary Predicate)

The indications for use for DentureID Microchip are virtually the same as the Primary ● Predicate because both are RFID micro-transponders and thev both respond with a unique identification number corresponding to a patient.
Both micro-transponders are passive and require energy from an outside source to . respond with a serial number.
Both micro-transponders are not tracking devices and are write-protected

Similarities between DentureID and SmartSponge (Reference Predicate)

Both are RFID micro-transponders and they both respond with a unique identification number.
Both RFID micro-transponders are embedded into LOCTITE M-31CL Medical Grade ● Ероху.

Differences between DentureID Microchip and VeriChip (Primary Predicate)

The micro-transponders use a different ISO standard. This difference does not raise any substantial equivalence concerns because VeriChip is designed to be read from a further distance because it is under the skin and the exact location may be unknown. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. Because DentureID Microchip requires close proximity read (<1 cm), it nearly impossible for an unauthorized person to obtain information related to the denture. This feature makes information from DentureID Microchip more secure than VeriChip.
The DentureID micro-transponder and epoxy encapsulating material do not touch the patient because the DFU requires covering the device with dental acrylic. However. the VeriChip encapsulated micro-transponder is located subcutaneously. This difference does not raise any substantial equivalence concerns because DenturelD is not invasive by design and results in lower patient risk.

Differences between DentureID and SmartSponge (Reference Predicate)

The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because SmartSponge is designed to be read from a further distance because they could be located in the abdomen and the exact location may be unknown or they could be located in the "out scanner bucket" grouped together. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read.

Applicable Standards

10993-1; Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process
ISO 1993-5; ISO MEM Elution Using L929, Mouse Fibroblast Cell (GLP) Cytotoxicity (2009)
ISO 1993-10; Biological Evaluation Of Medical Devices Part 10: Tests For Irritation ● And Skin Sensitization
ISO 7405 Evaluation of biocompatibility of medical devices used in dentistry ●
IEC 60601-1-2 International Medical Safety Standard 2014 ●
. F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force of Medical Devices in the Magnetic Resonance Environment 2015

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8. Non-Clinical Performance testing and Compliance

A. BIOCOMPATIBILITY
Description	Standard	Result
Cytotoxicity	ISO 10993-5:2009Biological Evaluation ofMedical Devices, Part 5:Tests for In VitroCytotoxicity	The test article scored '0'at 24, 48, and $72 \pm 4$hours and is considerednon-cytotoxic under theconditions of this test.
Irritation	SO 10993-10: 2010Standard, BiologicalEvaluation of MedicalDevices, Part 10: Testsfor Irritation and SkinSensitization	The differences in themean test and controlscores of the extractdermal observations wereless than 1.0, indicatingthat the requirementsof the ISO IntracutaneousReactivity Test have beenmet by the test article.
Sensitization	The study was conductedin accordance with ISO10993-10:2010. BiologicalEvaluation of MedicalDevices, Part 10: Testsfor Irritation and SkinSensitization, pp. 18-26	None of the negativecontrol animals challengedwith the control vehicleswere observed with asensitization responsegreater than '0'. None ofthe animals challengedwith the test articleextracts were observedwith a sensitizationresponse greater than '0'.The normal saline extractof the test material had asensitization response of'0' under valid testconditions. The sesame oilextract of the test materialhad a sensitizationresponse of '0' under validtest conditions. Under theconditions of this protocol,the test article did not elicita sensitization response.
Chemical Characterizationof Materials (Leachate)	Proprietary standards ofNelson Laboratories and	The incrementalsubstances found in the
ChemTech FordLaboratories	study are presented andcompared to toxicitystandards for therespective materials. As aresult of the study, we feelthat the potential toxicityfrom leaching of harmfulchemicals from theDentureID RFID tag is notsignificant.

A BIOCOMPATIBILITY

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B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION) -Passed

C. SOFTWARE VALIDATION - Passed

D. MIGRATION TESTING OF IMPLANTED TRANSPONDER - Passed

E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER - Passed

F. PERFORMANCE TESTING OF INSERTER - No inserter used

G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC

SCANNER - Responsibility of SmartPhone manufacturer

H. ELECTROMAGNETIC COMPATIBILITY

The following tests were completed on DentureID Microchips:

Description	Standard	Result
Radiated Emissions	EN 55011:2009	Pass
Electrostatic DischargeImmunity	EN 61000-4-2:2008	Pass
Radiated ElectromagneticField Immunity	EN 61000-4-3:2010	Pass
Magnetic Field Immunity	EN 61000-4-8:2009	Pass

I. ELECTRICAL SAFETY PERFORMANCE TESTING - The DentureID Microchip does not emit any energy, so safety performance testing is not required.

J. STERILITY - Device is not sterile

K. MAGNETIC RESONANCE IMAGING COMPATIBILITY

The following tests were completed on DentureID Microchips:

Description	Standard	Result
Magnetic Field Interactionsat 3-Tesla	(ASTM) Designation:F2052-15. StandardTest Method forMeasurement ofMagnetically InducedDisplacement Force onMedical Devices in theMagnetic ResonanceEnvironment.	The qualitativelymeasured torque at 3-Tesla for the DentureIDwas 0, no torque. Assuch, this device will notpresent an additional riskor hazard to a patient inthe 3-Tesla MRIenvironment or less with
		regard to torque.
MRI-related heating, 1.5-Tesla and 3-Tesla	ASTM Internationaldocument: AmericanSociety for Testing andMaterials International,Designation F2182-11aStandard Test Method forMeasurement of RadioFrequency InducedHeating On or NearPassive Implants DuringMagnetic ResonanceImaging	1.5-Tesla demonstrated amaximum of 1.5°Ctemperature rise and the3-T system demonstrateda 1.9°C rise. Both ofthese temperature risesmatched the maximumbackground temperaturerise. In conclusion, MRI1.5 and 3 do not inducesignificant heating toDentureID Microchip
Artifacts at 3-Tesla	(ASTM) InternationalDesignation: F2119-07(Reapproved 2013),Standard Test Method forEvaluation of MR ImageArtifacts from PassiveImplants	The artifacts thatappeared on the MRimages were shown aslocalized signal voids(i.e., signal loss) thatcorresponded to the sizeand shape of this device.The gradient echo pulsesequence producedlarger artifacts than theT1-weighted, spin echopulse sequence for thedevice. The maximumartifact size (i.e., as seenon the gradient echopulse sequence) extendsapproximately 10-mmrelative to the size andshape of this device.
Evaluation of the Effects ofMRI at 1.5-Tesla and 3-Tesla on the Function ofDentureID Microchip	The goal of thisinvestigation was todetermine the effects ofexposing the samples ofthe DentureID Microchipsto 1.5-Tesla/64-MHz and3-Tesla MRI conditionsand pulse sequencesselected to berepresentative of typicalclinical MRI techniques inorder to determine if thesedevices were damaged orif there was a change infunction.	DentureID Micochipsperformed 100% pre andpost exposures.

{22}------------------------------------------------

{23}------------------------------------------------

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: This standard has been addressed in Section 16.

ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry: This standard has been addressed in Section 16.

9. Conclusions

DentureID Microchip does not require a specialized reader
After reading a Denture ID Microchip, the information returned to the reader is robust and detailed compared to VeriChip which returns only two rows of 15 character alphanumeric strings.

Regulation Number and Section

§ 880.6300 Implantable radiofrequency transponder system for patient identification and health information.

(a)
Identification. An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.