(50 days)
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No
The summary describes a material for fabricating orthodontic appliances with added flavoring, and there is no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device is an orthodontic appliance used for fabrication and retention, not for therapeutic treatment.
No
The device is used for fabrication of orthodontic appliances for correction of malocclusions or post-treatment retention, and its description does not indicate any diagnostic function.
No
The device description explicitly states it is an orthodontic appliance using physical components like stainless steel wire and polymer/monomer, indicating it is a hardware device, not software-only.
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 "fabrication of flavored/fragranced orthodontic appliances." This is a device used in the mouth to correct malocclusions or for retention.
- Device Description: The description confirms it's an "orthodontic appliance" made of standard materials and a flavored resin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used outside the body to analyze biological samples. This device is used inside the body as a physical appliance.
N/A
Intended Use / Indications for Use
Aromacryl's relining, repairing/rebasing resin is indicated for the fabrication of flavored/fragranced orthodontic appliances.
Product codes
EBI
Device Description
The Aromacryl device is an orthodontic appliance using industry standard stainless steel wire and Aromacryl polymer and monomer. Aromacryl can be used to fabricate devices, such as orthopedic and functional appliances to correct malocclusions or post-treatment retention devices known as hawley retainers. The Aromacryl product offers the patient a pleasant tasting appliance by the addition of FDA approved food grade flavoring that is GRAS (Generally Recognized As Safe) for this application. The predicate substantially equivalent devices sited may have a somewhat plastic taste. The Aromacryl device would offer the patient a choice of an enjoyable flavor and fragrance.
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)
Not Found
Reference Device(s)
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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
KQ2112)
MAY 2 8 2002
Image /page/0/Picture/2 description: The image shows a stylized letter 'a' in a square frame. The letter 'a' is in a cursive font and is black. The frame around the letter is a square with a black border. The background of the frame is white. The image has a gray border around the frame and a shadow effect on the right side.
Aromacryl, LLC
1013 East Third Street, Royal Oak, MI 48067 (248) 544-0860
510(k) Summary
Date of Summary: Submitter: Address: Contact Person: Telephone Number: March 27, 2002 Aromacryl, LLC 1013 East Third Street, Royal Oak, MI 48067 Tanya L. Woods (248) 544-0860
Name of Device:
Aromacryl flavored/fragranced Orthodontic Appliance
Classification Name:
Resin, denture, relining, rebasing
The Aromacryl device is an orthodontic appliance using industry standard stainless steel wire and Aromacryl polymer and monomer. Aromacryl can be used to fabricate devices, such as orthopedic and functional appliances to correct malocclusions or post-treatment retention devices known as hawley retainers. The Aromacryl product offers the patient a pleasant tasting appliance by the addition of FDA approved food grade flavoring that is GRAS (Generally Recognized As Safe) for this application. The predicate substantially equivalent devices sited may have a somewhat plastic taste. The Aromacryl device would offer the patient a choice of an enjoyable flavor and fragrance.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2002
Ms. Tanya L. Woods President Aromacryl, LLC 1013 East Third Street Royal Oak, Michigan 48067
Re: K021121
Trade/Device Name: Aromacryl Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 27, 2002 Received: April 08, 2002
Dear Ms. Woods:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becaremined the device is substantially equivalent (for the releveloca doore 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 mendie comments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to arrestic 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 econdements 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 (1 wr ), it har ot be doges in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in farther announcements concerning your device in the Federal Register.
2
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 modi that I Dr may Federal statutes and regulations administered by other Federal agencies. or the For of all , I with all the Act's requirements, including, but not limited to: registration 1 od intine compry with a mart 807); labeling (21 CFR Part 801); good manufacturing practice and instills (= = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = 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 This lotter will and in your of 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance 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, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Ultrad
Timothy A. Director Division of Dental, Infection Control, and General Hospital Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
Aromacryl's relining, repairing/rebasing resin is indicated for the fabrication of flavored/fragranced orthodontic appliances.
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_100