· Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances
· Temporary and/or permanent plastic/composite crowns and bridges
· Custom splinting for immobilization of teeth

Device Description

Perma Fiber / Perma Mesh glass fiber reinforcement material

AI/ML Overview

This document is a 510(k) summary for the Perma Fiber / Perma Mesh dental reinforcement material. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for a diagnostic or AI-driven device.

The provided text describes the administrative information, device name and classification, and intended use. The FDA letter confirms the substantial equivalence determination for marketing based on the information provided in the 510(k) submission.

Therefore, I cannot extract the requested information in the format provided because the document type does not typically elaborate on clinical study design, performance metrics, ground truth establishment, or multi-reader multi-case studies for this type of dental material.

In summary, the 510(k) process for a device like "Perma Fiber / Perma Mesh" primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing material properties, design, and intended use, rather than extensive clinical studies with specific performance metrics and ground truth as would be seen for a diagnostic or AI device.

Therefore, many of the requested fields are not applicable or the information is not present in the provided 510(k) summary.

Here's how the information would be presented if it were available in this document:

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

Not Applicable/Information Not Present in the Provided Document: For a dental material like Perma Fiber/Perma Mesh, acceptance criteria would typically relate to physical and mechanical properties (e.g., flexural strength, bond strength, wear resistance, biocompatibility) as measured in benchtop or in vitro studies. No specific acceptance criteria or corresponding device performance results are detailed in this 510(k) summary. The summary focuses on regulatory clearance based on substantial equivalence.

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

Not Applicable/Information Not Present: This document does not describe a "test set" in the context of clinical performance evaluation or data analysis for a diagnostic or AI device.

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

Not Applicable/Information Not Present: Ground truth establishment by experts is typically relevant for diagnostic devices or AI applications. This document does not describe such a process.

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

Not Applicable/Information Not Present: Adjudication methods are relevant for resolving discrepancies in expert opinions for diagnostic ground truth. This is not applicable to this 510(k) summary.

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/Information Not Present: Perma Fiber / Perma Mesh is a physical reinforcement material, not a diagnostic tool or an AI-assisted device. Therefore, MRMC studies are not relevant.

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

Not Applicable/Information Not Present: This device is not an algorithm.

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

Not Applicable/Information Not Present: "Ground truth" as a concept for performance evaluation is not relevant for this material's 510(k) submission. For materials, the "truth" would be adherence to specified material properties and biocompatibility.

8. The sample size for the training set

Not Applicable/Information Not Present: There is no "training set" as this is not an AI or machine learning device.

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

Not Applicable/Information Not Present: There is no "training set" or associated ground truth for this type of device.

Summary

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510(k) Summary

K 0 82180

Perma Fiber / Perma Mesh

510(k) Summary

Angelus Industria de Productos Odontologicos Perma Fiber / Perma Mesh

DEC 1 7 2008

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Angelus Industria de Productos Odontologicos Waldir Landgraf, 101 Londrina, Brazil 86031-218 Telephone: +55 43 2101 3200 Fax: +55 43 2101 3201

Official Contact:

Representative/Consultant:

Marco Canonico

Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Codes: Classification Panel: Reviewing Branch:

Perma Fiber /Perma Mesh glass fiber reinforcement material resin, denture, relining, repairing, rebasing Class II, 21 CFR 872.3760 EBI Dental Products Panel Dental Devices Branch

INTENDED USE

Perma Fiber / Perma Mesh is indicated for use as reinforcement for:

· Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances
· Temporary and/or permanent plastic/composite crowns and bridges
· Custom splinting for immobilization of teeth

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Angelus Industria de Productos Odontologicos C/o Ms. Linda K. Schulz, RDH, BSDH Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

DEC 1 7 2008

Re: K082180

Trade/Device Name: Perma Fiber / Perma Mesh Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 24, 2008 Received: November 25, 2008

Dear Ms. Schulz:

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 - Ms. Schulz

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clive S.

Chiu S. Lin. Ph. D Division 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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510(k) Premarket Notification

Perma Fiber / Perma Mesh

Indications for Use

510(k) Number (if known):

Device Name:

Perma Fiber / Perma Meslı

Indications for Use:

Perma Fiber / Perma Mesh is indicated for use as reinforcement for:

· Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances
· Temporary and/or permanent plastic/composite crowns and bridges
· Custom splinting for immobilization of teeth

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swer Rume

510(k) Number:

Page 1 of

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

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.