(50 days)
Flexacryl Soft
Not Found
No
The summary describes a chemically cured soft denture reline material and its performance characteristics, with no mention of AI or ML technology.
No
The device is a material used for relining dentures, which is a restorative/prosthetic purpose. While it contributes to patient comfort and the proper fit of a denture, its primary function is not to cure, mitigate, treat, or prevent a disease or condition in a therapeutic sense, but rather to aid in the mechanical fit and function of a prosthetic device.
No
Explanation: The device, Metacryl, is described as a material for fabricating soft relines for dentures. Its intended use is to alter the fit or comfort of dentures, not to diagnose a disease or condition. The performance studies focus on material properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states "Metacryl is a chemically cured soft denture reline," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the chairside fabrication of soft relines for dentures." This is a direct treatment or modification of a medical device (a denture), not a test performed on a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description focuses on the material and its use in fabricating a denture reline.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health
Therefore, Metacryl is a dental material used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Metacryl™ is intended for the chairside fabrication of soft relines for dentures.
Product codes
EBI
Device Description
Metacryl is a chemically cured soft denture reline. All components have been used in legally marketed devices or have been found to be safe for dental use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Metacryl was evaluated as follows: Mechanical propertics, Hardness, Water absorption, Discoloration, Peel strength
Metacryl was also evaluated as follows: ISO Agar Overlay Cytotoxicity Test non-cytotoxic
Key Metrics
Not Found
Predicate Device(s)
Flexacryl Soft
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAY 2 5 2004
Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo is a circle with the words "GREAT LAKES ORTHODONTICS" around the outside. In the center of the circle is an outline of the United States with the Great Lakes shown in white. The logo is black and white.
K04088,
Great Lakes Orthodontics, LTD.
An Employee Owned Company
Our Vision "Delight our customers. Respect and help our co-workers."
510(k) SUMMARY
Great Lakes Orthodontics 800-828-7626 CONTACT PERSON: Mr. Mark Lauren mlauren@greatlakesortho.com
DATE PREPARED: April 2, 2004
TRADE OR PROPRIETARY NAME: Metacryl COMMON NAME: Dental acrylic, soft denture reline CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872.3760 PRODUCT CODE: EBI
Lang Dental Corporation PREDICATE DEVICE: Flexacryl Soft 175 Messner Drive Wheeling, IL 60090 800-222-5264
DEVICE DESCRIPTION
Metacryl is a chemically cured soft denture reline. All components have been used in legally marketed devices or have been found to be safe for dental use.
INTENDED USE Mctacryl is intended for the chairside fabrication of soft denture reline.
TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE Metacryl was evaluated as follows: Mechanical propertics, Hardness, Water absorption, Discoloration, Peel strength
Metacryl was also evaluated as follows:
ISO Agar Overlay Cytotoxicity Test non-cytotoxic
We conclude that the similarity in composition between Metacryl and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Metacryl for the indicated uses.
200 Cooper Avenue · P.O. Box 5111 · Tonawanda, New York 14151-5111 ・ · 800-828-7626 Fax (716) 871-0550 716-871-1161 e-mail: info@greatlakesortho.com · Website: www.greatlakesortho.com
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2004
Mr. Mark Lauren Great Lakes Orthodontics, Limited 200 Cooper Avenue P.O. Box 5111 Tonawanda, New York 14151-5111
Re: K040881
Trade/Device Name: MetacryI™ Soft Denture Reline Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Codc: EBI Dated: April 2, 2004 Received: April 6, 2004
Dear Mr. Lauren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the receiced above and 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 approvisions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), I may of 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. Lauren
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 moun that 1 Drives and regulations administered by other Federal agencies. or the Fet of any a vith 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 and fisting (21 certer in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) I mis letter notification. The FDA finding of substantial equivalence of your device to a premainer results in a classification for your device and thus, pour 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), 11 you dontact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the mitj overnit 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/dsma/dsmamain.html
Sincerely yours,
Charles
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
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150
Device Name: Metacry|™ soft denture reline
Indications for Use:
Metacryl ™ is intended for the chairside fabrication of soft relines for dentures.
Prescription Use ﺴﺴﺎ (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rung
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Kouck 510(k) Number:_