TALON and REVERE are a moldable acrylic compound for use in the fabrication, of TMJ/D Splints / Night Guards / Anti-Bruxism Guards / Mouth Guards / Sleep Apnea Anti-Snore Appliances / Liners, and/or Relines for Complete and Partial Dentures / Gaskets for Overdentures / and other dental prostheses device appliances as prescribed.

Device Description

The submitted devices, TALON® and REVERE are a thermoplastic moldable acrylic compound for use in the fabrication, repair and relining of complete and/or partial dentures, dental appliances, and dental prostheses devices, including gaskets for over dentures, splints, night guards and sleep apnea anti-snore devices, and other appliances as prescribed.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical devices, TALON® and REVERE®, which are thermoplastic moldable acrylic compounds for dental use. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding AI/human reader studies, ground truth establishment, and specific sample sizes for training/test sets is not applicable to this type of regulatory submission.

However, based on the provided text, I can infer the acceptance criteria or performance characteristics expected of the device, and the evidence presented to demonstrate these characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence to existing predicate devices, the "acceptance criteria" are essentially the characteristics and performance attributes of the predicate devices. The study performed is a demonstration that the new devices (TALON® and REVERE®) possess these same characteristics.

Acceptance Criteria (Characteristic of Predicate Devices)	Reported Device Performance (TALON® & REVERE®)
Thermoplastic moldable acrylic	YES
Used for fabrication, repair, relining of dentures, dental appliances, prostheses devices	YES
Excellent bond to methacrylates	YES
Premixed for immediate use and safety	YES
Repairable	YES
Two (2) hour curing time at 155°F	YES
Will not leach out plasticizers into the oral cavity	YES
Can be processed in the ½ denture flask method	YES
Can be laminated without adhesives or bonding agents	YES
Has a "memory" and will not warp under normal wear and handling	YES
Residual monomer level (up to 0.14%)	Verified at 0.14% by Gas Chromatographic studies
Shore-D hardness testing shows no hardening over time	Identical results to new appliance after 1 year of use
Eliminates undercut wax-out	YES
Biocompatibility: No cytotoxicity	No evidence of causing cell lysis or toxicity
Biocompatibility: No dermal sensitization (guinea pig)	No evidence of delayed dermal contact sensitization
Biocompatibility: Non-irritant to vaginal mucosal tissue (rabbit)	Non-irritant
Biocompatibility: Negligible skin irritation (rabbits)	No erythema, no edema; Primary Irritation Index 0.0

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- Residual Monomer Level: Not explicitly stated, but gas chromatographic studies were performed.
- Shore-D Hardness: Appliances after 1 year of continuous use compared to a new appliance. The number of appliances tested is not specified.
- Biocompatibility Testing: Not explicitly stated for each test, but standard in-vitro (cytotoxicity) and in-vivo (sensitization, irritation) tests were performed using biological samples (guinea pigs, rabbits) as per ISO standards.
Data Provenance:
- Residual Monomer Level: Verified testing results completed through Gas Chromatographic studies performed by Cyro Industries of Orange, Connecticut.
- Shore-D Hardness: Testing performed by Braun-Intertec of Portland, Oregon. TMJ/D appliances were used.
- Biocompatibility Testing: Contracted with NAMSA, 9 Morgan, Irvine, California 92618. Samples of REVERE® were used, as it is identical to TALON® except for colorant.
- Retrospective/Prospective: The testing described appears to be prospective validation testing conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Residual Monomer Level: Experts at Cyro Industries (details not provided).
Shore-D Hardness: Experts at Braun-Intertec (details not provided).
Biocompatibility: Experts at NAMSA, a qualified testing laboratory.
Other characteristics: The statement mentions "Consultation with Dr. Frances Storrs, MD. a dermatologist at Oregon Health Sciences University in Portland, Oregon whose area of research is contact dermatitis of acrylics, stated in her opinion I could not have selected a safer acrylic." This is an expert opinion, but not explicitly used to establish "ground truth" for the test set in the same way laboratory results are.

4. Adjudication method for the test set

Not applicable. The tests performed are objective laboratory and preclinical (animal) tests with defined endpoints, not subjective human assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for a dental material, not an AI-powered diagnostic device.

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

Not applicable. This is a material, not an algorithm or software.

7. The type of ground truth used

Objective lab measurements: Gas chromatography for monomer levels, Shore-D hardness testing.
Preclinical animal studies: Cytotoxicity via ISO elution method, ISO Maximization Sensitization Study (guinea pigs), ISO Vaginal Irritation Study (rabbits), ISO Skin Irritation Study (rabbits).
Comparison to predicate device characteristics: The fundamental "ground truth" for substantial equivalence is that the new device shares the same fundamental technological characteristics and performs as safely and effectively as the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of material device submission, as it does not involve machine learning or AI.

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

Not applicable, as there is no training set.

Summary

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11071245 PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92

AUG - 2 2007 Device Name - as required by 807.92(a)(2): Trade Names: TALON® and REVERE® Common/Classification Name: Denture resin, relining, repairing or rebasing resin Classification Regulation: 872.3760 Device Class: Class II Product Code (Procode): EBI Premarket Notification submitter: Company Name: Talon Acrylics, Inc. 850 N. E. 102nd Ave., Portland, OR 97220 Company Address: Contact: Sherman Watson, President Preparation Date: April 27, 2007

LEGALLY MARKETED PREDICATE DEVICE - as required by 807.92(a)(3) A.

Two (2) of the legally marketed predicate devices identified by the submitter are the presently marketed Comfor-dent Denture Liner, K910795, and Comfort Acrylics Pliable Denture Liners and Splints, K900799, both devices also manufactured by Comfort Acrylics Company (now "Inc.), 2103 NE 27200 Ave, Camas, WA. Both predicate devices are listed as "Resin, Denture, Relining, Repairing, Rebasing," devices, regulation number "872.3760," and Product Code "EBI," for which Comfort Acrylics, Inc. is Licensed to Manufacture and Distribute for Sale, TALON® Thermoplastic composition via Licensing Agreement through Sherman L. Watson / Talon Acrylics, Inc.

B. DEVICE DESCRIPTION - as required by 807.92(a)(4)

The main characteristics of the submitted devices includes:

1. A thermoplastic moldable acrylic
1. Used for fabrication, repair and relining of complete and/or partial dentures, dental appliances and dental prostheses devices to include all the above.
1. Excellent bond to methacrylates

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1. Premixed for immediate use and safety
1. Repairable
1. Two (2) hour curing time at 155 F
1. Will not leach out plasticizers into the oral cavity
1. Can be processed in the 1/2 denture flask method
1. Can be laminated without the use of adhesives or bonding agents
1. Has a "memory" and will not warp under normal wear and handling procedures
1. Gas chromatographic studies verify a residual monomer level of up to 0.14%
1. Shore-D hardness testing shows it will not harden over time under normal wear and handling conditions
1. Eliminates undercut wax-out
1. No need to survey model
1. Not necessary to duplicate models

C. DEVICE CLAIMS - as required by 807.92(a)(4)

TALON® and REVERE® are a thermoplastic moldable acrylic compound for use in the fabrication, repair and relining of complete and/or partial dentures, dental appliances, and dental prostheses devices, including gaskets for over dentures, splints. night guards and sleep apnea anti-snore device appliances as prescribed.

PRODUCT AND TECHNICAL SPECIFICATIONS - as required by D. 807.92(a)(4)

TALON® and REVERE® thermoplastic moldable acrylic compounds are the same predicate devices as Comfor-dent Denture, K910795 and Comfort Acrylics Pliable Denture Liners and Splints, K900799.

The manufacturer of TALON® and REVERE® is registered with the FDA and has implemented a Quality System which includes Manufacturing Process Validation Records, Equipment Validation Records, Specification Records, Acceptance Criteria Records. Work Instructions, and Finished Device Acceptance Reports on Records on file, to include Monomer, Polymer, Colorants, Purchasing/Manufacturing, Labeling, Packaging, and Shipping.

E. INTENDED USE - as required by 807.92(a)(5)

TALON® and REVERE® are thermoplastic moldable acrylic compounds used by dental professionals for the fabrication, repair and relining of complete and/or partial dentures, dental appliances and dental prostheses devices including TMJ/D Splint Appliances, Night Guards, Sleep Apnea Anti-Snore, Appliances, Athletic Mouth Guards, Fluoride Trays, Repositioning Stints, and other moldable appliances as prescribed. The REVERE® device is the same thermoplastic moldable acrylic compound with the addition of a customer requested coloring agent from a list of Talon Acrylic's agents intended for use in dental appliances and prostheses.

F. INDICATIONS FOR USE

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TALON® and REVERE® are a moldable acrylic compound for use in the fabrication, repair and relining of complete and/or partial dentures, dental appliances, and dental prostheses devices, including gaskets for over dentures, splints, night guards and sleep apnea anti-snore devices, and other devices as prescribed.

TECHNOLOGICAL CHARACTERISTICS SUMMARY – as required by G. 807.92(a)(6)

To the submitter's knowledge, there are no technological characteristic differences between the submitted devices, TALON® and REVERE® and the predicate devices, Comfor-dent Denture Liner, K910795 and Comfort Acrylics Pliable Denture Liners and Splints, K900799.

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TALON and REVERE and the PREDICATE DEVICE(S)TABLE OF DIFFERENCES BETWEEN

Characteristic	TALON®	REVERE®	Comfor-Dent Denture Liner, K910795	Comfort Acrylics Pliable Denture Liners & Splints, K900799
Thermoplastic moldable acrylic	YES	YES	YES	YES
Used for fabrication, repair and relining of dentures, dental appliances and dental prostheses devices	YES	YES	YES	YES
Excellent bond to methacrylates	YES	YES	YES	YES
Premixed for immediate use and safety	YES	YES	YES	YES
Repairable	YES	YES	YES	YES
Two (2) hour curing time at 155°F	YES	YES	YES	YES
Will no leach out of plasticizers into the oral cavity	YES	YES	YES	YES
Can be processed in the ½ denture flask method	YES	YES	YES	YES
Can be laminated without the use of adhesives or bonding agents	YES	YES	YES	YES
Has a "memory" and will not warp under normal wear and handling procedures	YES	YES	YES	YES
Gas chromatographic studies verify a residual monomer level of up to 0.14%	YES	YES	YES	YES
Shore-D hardness testing shows it will not harden over time under normal wear and handling conditions	YES	YES	YES	YES
Eliminates undercut wax-out	YES	YES	YES	YES
Includes a customer specified colorant	NO	YES	NO	NO

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H. NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1)

SUMMARY:

Predicate devices:

Comfort Acrylies Company (now Comfort Acrylics Company, Inc.) is the owner of the predicate devices. The submitter, Mr. Watson, directed performance testing and validation of the submitted devices initially submitted in January, 1990, with FDA authorization to market the devices initially dated May 15, 1990, coupled with follow up submissions, throughout 1990 and continued FDA authorization to market the devices continued throughout 1991, with 510(k)'s K910795 and K900799. In July, 1998 a submission in reference to the addition of a colorant to the above submissions trademarked as Revere® was submitted to FDA, with a Substantial Equivalence letter from FDA dated August 19, 1998 subsequently received.

Submitted devices:

Submitter claims that the predicate devices and the submitted devices are manufactured, under existing executed agreements, to patent specifications [the patent is owned by the submitter] and detailed in those executed agreements between the submitter and Comfort Acrylics Company (now Comfort Acrylics Company, Inc.) the owner of the predicate devices.

Non-Clinical Testing

The submitted devices have undergone significant verification and validation testing. Validation testing included testing of Talon® and/or Revere® manufacturing processes at the University of Washington Chemistry Department during the development of Talon® by Sherman L. Watson, with verified testing results completed through Gas Chromatographic studies performed by Cyro Industries of Orange, Connecticut, which indicated a 0.14% unreacted monomer immediately following polymerization. Their conclusion indicated this is a very low number in polymer chemistry and very satisfactory for uses in dentistry.

Shore-D hardness testing was performed by Braun-Intertec of Portland, Oregon of TMJ/D appliances after 1 year of continuous use, compared to a new appliance, yielded identical results indicating no change of hardness over time. No loss of resiliency, nor retention have ever been reported.

Consultation with Dr. Frances Storrs. MD. a dermatologist at Oregon Health Sciences University in Portland, Oregon whose area of research is contact dermatitis of acrylics, stated in her opinion I could not have selected a safer acrylic.

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The performance data records documents that TALON® and REVERE® met their stated requirements and design specifications as intended.

Biocompatibility Data

Finally, the submitter contracted with a qualified testing laboratory, NAMSA, 9 Morgan, Irvine, California 92618, to perform biocompatibility testing on the finished device in the form intended to be used and to come in contact with a patient using an appropriate dental device. The biocompatibility testing was performed utilizing samples of REVERE® which is exactly the same as TALON® except of the addition of a specified colorant.

The tests performed included:

1. Cytotoxicity Study Using the ISO Elution Method, (1X MEM Extract)
1. ISO Maximization Sensitization Study Extract in 0.9% sodium chloride USP
1. ISO Maximization Sensitization Study -- Extract in sesame oil. NF (SO)
1. ISO Vaginal Irritation Study Extract in 0.9% sodium chloride USP
1. ISO Vaginal Irritation Study Extract in sesame oil, NF (SO)
1. ISO Skin Irritation Study

The test results indicated [based on the above list]:

1. No evidence of causing cell lysis or toxicity
1. The SC test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig
1. The SO test article extract showed no evidence of causing delayed dermal contact sensitization in the guinea pig
The SC test article extract would be considered a nonirritant to the vaginal 4. mucosal tissue of the rabbit
1. The SO test article extract would be considered a nonirritant to the vaginal mucosal tissue of the rabbit
1. No erytherma and no edema were observed on the skin of the rabbits. The Primary Irritation Index for the test article as calculated to be 0.0. The response to the test article was categorized as negligible.

The results of this biocompatibility data confirms that TALON® and REVERE® met its requirements, design specifications, and has been determined by the above named laboratory to be "biocompatible" as intended.

The submitter believes that the predicate devices. Comfor-Dent Denture, K910795 and Comfort Acrylics Pliable Denture Liners and Splints, K90079's 510(k) submission did NOT include summaries of non-clinical testing data and biocompatibility testing data.

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The submitter believes Talon Acrylics Inc.'s submitted TALON and REVERE's summary of non-clinical testing and biocompatibility testing data further documents the submitter's claim of substantial equivalence.

I. SUBSTANTIAL EQUIVALENCE SUMMARY

The submitted devices, TALON® and REVERE®, have the same indications for use as the predicate device(s), Comfor-dent Denture, K910795 and Comfort Acrylics Pliable Denture Liners and Splints, K900799.

TALON® and REVERE® both have the same or very similar technological characteristics as the predicate device(s). However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation, biocompatibility testing in compliance with 807.92(b)(2). and performance testing to further document substantial equivalence. The results of this testing substantiates that TALON® and REVERE® performs the same results as the predicate devices.

J. CONCLUSIONS:

The device characteristics, performance testing and biocompatibility testing data document that TALON® and REVERE® devices are substantially equivalent to the predicates Comfor-dent Denture, K910795 and Comfort Acrylics Pliable Denture Liners and Splints, K900799, which are registered as my Talon® Thermoplastic Acrylic Elastomer Polymers.

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Image /page/7/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three overlapping, curved lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circular border of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 2 2007

Mr. Sherman Watson President Talon Acrylics, Incorporated 850 N.E. 102nd Avenue Portland, Oregon 97220

Re: K071245

Trade/Device Name: TALON and REVERE Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: July 03, 2007 Received: July 06, 2007

Dear Mr. Watson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Watson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K071245

Device Names: TALON and REVERE

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Marley for MSR

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K071245

Page 1 of 1

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.