PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440

K082180 · Angelus Industria DE Productos Odontologicos · EBI · Dec 17, 2008 · Dental

Device Facts

• Record ID: K082180
• Device Name: PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
• Applicant: Angelus Industria DE Productos Odontologicos
• Product Code: EBI · Dental
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

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

Device Story

Perma Fiber / Perma Mesh is a glass fiber reinforcement material used in dental applications. It is incorporated into plastic or composite resins during the fabrication or repair of dental prosthetics and appliances. The device provides structural reinforcement to full or partial dentures, overdentures, orthodontic appliances, crowns, bridges, and splints for tooth immobilization. It is intended for use by dental professionals in a clinical setting. By reinforcing the resin matrix, the device enhances the mechanical properties of the final dental restoration or appliance, potentially increasing durability and resistance to fracture for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Glass fiber reinforcement material. Form factor consists of fibers or mesh designed for integration with dental resins. No specific ASTM standards or software components described.

Indications for Use

Indicated for patients requiring reinforcement of dental prosthetics, including full/partial dentures, overdentures, orthodontic appliances, temporary/permanent plastic or composite crowns and bridges, and custom splinting for tooth immobilization.

Regulatory Classification

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.

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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: [phone] Fax: [phone] email: [e-mail] [e-mail]

### 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 [phone]. 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 [phone] or [phone] 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:

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