(63 days)
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No
The summary describes a chemically cured soft dental acrylic and its physical and biocompatibility properties. There is no mention of AI, ML, image processing, or any other computational technology that would suggest the use of AI/ML.
No
The document states that Variflex is a dental acrylic intended for laboratory fabrication of dental appliances like interocclusal splints and night guards. While these appliances can have therapeutic effects (e.g., reducing teeth grinding), the device itself is a material used to create the appliance, not a therapeutic device in itself.
No
Explanation: The device, Variflex™, is described as a chemically cured soft dental acrylic intended for the laboratory fabrication of dental appliances like splints and night guards. Its intended use is for manufacturing, not for identifying or investigating a disease or condition.
No
The device description clearly states "Variflex 100 is a chemically cured soft dental acrylic," 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 "laboratory fabrication of dental appliances such as interocclusal splints and night guards." This describes a material used to create a physical device for use in the patient's mouth, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: It's described as a "chemically cured soft dental acrylic." This is a material, not a diagnostic test or reagent.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The performance studies focus on the physical and biocompatibility properties of the material itself, which is consistent with a dental material used for fabrication.
N/A
Intended Use / Indications for Use
Variflex™ is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
Product codes
EBI
Device Description
Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
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
laboratory fabrication
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)
Variflex™ was evaluated as follows: Mechanical properties, Hardness, Water absorption, Discoloration Variation of physical properties with temperature Variflex™ was also evaluated as follows: MEM Elution Test non-cytotoxic Mucous membrane irritation non-irritant Kligman Maximization Test (NaCI) non-sensitizer
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
Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo features a black and white image of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a circular fashion above the image, and the word "ORTHODONTICS" is written in a circular fashion below the image.
JAN 2 1 2004
Great Lakes Orthodontics, LTD.
An Employee Owned Company
Our Vision "Delight our customers. Respect and help our co-workers."
510(k) SUMMARY
CONTACT PERSON: Mr. Mark Lauren Great Lakes Orthodontics 800-828-7626 mlauren(a)greatlakesortho.com
DATE PREPARED: November 10, 2003
TRADE OR PROPRIETARY NAME: Variflex™ COMMON NAME: Dental acrylic, heat-softening acrylic CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872,3760 Product Code: EBI
PREDICATE DEVICE:
Clearsplint™ Astron Dental Corporation 815 Oakwood Road Unit G Lake Zurich, IL 60047 800-323-4144
DEVICE DESCRIPTION
Variflex 100 is a chemically cured soft dental acrylic. All components have been used in legally marketed devices or have been found to be safe for dental use.
INTENDED USE
Variflex " is intended for the laboratory fabrication of dental appliances such as interocclusal splints and night guards.
TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE Variflex™ was evaluated as follows:
Mechanical properties, Hardness, Water absorption, Discoloration Variation of physical properties with temperature
Variflex™ was also evaluated as follows: MEM Elution Test
non-cytotoxic Mucous membrane irritation non-irritant Kligman Maximization Test (NaCI) non-sensitizer
We conclude that the similarity in composition between Variflex " and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Variflex™ for the indicated uses.
200 Cooper Avenue • P.O. Box 5111 • Tonawanda, New York 14151-5111 716-871-1161 · · 800-828-7626 · · · Fax (716) 871-0550 e-mail: info@greatlakesortho.com · · Website: www.greatlakesortho.com
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. Mark Lauren Director of Research Great Lakes Orthodontics, Ltd. 200 Cooper Avenue Tonawanda, New York 14151-511
Re: K033632
Trade/Device Name: Variflex™ Heat Softening Acrylic Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 17, 2003 Received: December 01, 2003
Dear Mr. Lauren:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enerosure/ to regary than of the Medical Device Amendments, or to devices that prior to May 26, 1770, the chactions and the provisions of the Federal Food, Drug, and Cosmetic liave been reclassince in accordance wof a premarket approval application (PMA). You may, ACt (Act) that do not require apple far the general controls provisions of the Act. The general therefore, mance the device, babyest er an irements for annual registration, listing of devices, good Controls provisions of clibeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classifica (see ao ro) into existing major regulations affecting your device can be may be subject to such additional volta of the 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
2
Page 2 – Mr. Mark Lauren
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 premated 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 in you don't openite at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, and as reflecting or and mentitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may 1 at to in of 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/dsma/dsmamain.html
Sincerely yours,
Carl
Chiu S. Lin. PhD 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): K033632
Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150
Device Name: Variflex™ heat softening acrylic
Indications for Use:
Variflex™ is intended for the laboratory fabrication of dental appliances such as splints and night guards.
Prescription Use (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 Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K033632
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