(138 days)
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No
The provided text describes a glass fiber reinforcement material for dental and orthodontic applications and contains no mention of AI or ML.
No
The device is a reinforcement material used in dentistry for manufacturing or repairing dental prosthetics and appliances, and for custom splinting. Its function is structural reinforcement rather than directly treating a disease, injury, or medical condition.
No
The device is described as a reinforcement material for dental and orthodontic appliances, crowns, bridges, and splinting. Its intended use is mechanical reinforcement, not the identification of diseases or conditions.
No
The device description clearly states it is a "glass fiber reinforcement material," which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a reinforcement material for dental and orthodontic appliances, crowns, bridges, and splinting teeth. These are all applications that involve working with materials outside of the human body, but not for the purpose of diagnosing a condition based on analyzing samples from the body.
- Device Description: The description simply states it's a glass fiber reinforcement material. This aligns with its use as a structural component in dental devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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
1
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
3
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