(35 days)
No
The summary describes a physical material (glass fibers and polymer/resin matrix) used for orthodontic retainers. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a glass-fiber reinforcement for orthodontic retainers, which are used to maintain the alignment of teeth after orthodontic treatment, thus serving a therapeutic function in correcting or preventing a physical impairment (misaligned teeth).
No
This device is a glass-fiber reinforcement for orthodontic retainers, a structural component, not something used to diagnose a medical condition.
No
The device description clearly states it is a "semi-manufactured product made of glass fibers and polymer/resin matrix," 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 "GLASS-FIBER REINFORCEMENT FOR ORTH-DONTIC RETAINERS." This describes a material used in the mouth for structural support of orthodontic appliances.
- Device Description: The description details a "semi-manufactured product made of glass fibers and polymer/resin matrix." This is a physical material, not a diagnostic test.
- 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 substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVDs are used to perform tests outside the body on biological specimens to provide information about a person's health. This device is a material used inside the body for a structural purpose.
N/A
Intended Use / Indications for Use
As orthodontic retainer
GLASS-FIBER REINFORCEMENT FOR ORTH-DONTIC RETAINERS
Product codes
EBI, DYT
Device Description
everStick™ ORTHO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ ORTHO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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
Koz n2le
510(k) Summary u
Stick Tech Ltd, PO Box 114, 20521 Turku, Finland Applicant: Tel: +358-2-4808 2558 Fax: +358-2-241 0032 Ilkka Kangasniemi, Ph.D. Contact Person: William M. Troetel, Ph.D. U.S. Agent to respond to 80 Parkway West FDA requests: Mount Vernon, NY 10552 Tel: (914) 664-1640 Fax: (914) 667-3993 wtroetel@westnet.com April 4, 2002 Date Prepared: everStick™ ORTHO Device Trade Name: Device Common Name: Glass fiber orthodontic retainer Denture relining, repairing, or rebasing resin Device Classificaton Name: (21 CFR §872.3760)
Description of Device:
everStick™ ORTHO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ ORTHO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
Intended Use: As orthodontic retainer
everStick™ ORTHO is substantially equivalent to everStick™, approved under 510(k) number K011788 dated November 7, 2001.
The composition of everStick™ ORTHO is equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different. The indication for use in orthodontics supplements the indications for use to be done with the predicate device.
1
By comparing the ingredients of everStick ORTHO to the existing data available from dental polymerizable material, it can be stated that everStick ORTHO does not expose the dentist nor the patient to unacceptable risks.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest movement and dynamism.
Public Health Service
MAY 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stick Tech. Limited C/O William M. Troetel, Ph.D., LLC 80 Parkway West Mount Vernon, New York 10552
Re: K021126
Trade/Device Name: everStick™ ORTHO Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and DYT Dated: April 05, 2002 Received: April 08, 2002
Dear Dr. Troetel:
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 appeared were in 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 (1 ra )) var 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.
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.
3
Page 2 - Dr. William M. Troetel
You must comply with all the Act's requirements, including, but not limited to: registration r ou must compry was and many (21 CFR Part 801); good manufacturing practice and ilsung (21 CF R Part 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as bet rent in aroduct 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 1111s letter will and in yours of the FDA finding of substantial equivalence of your device to 910(x) promation nowledge 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 11 you debire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and catalians in onal (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" (21 CFR 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,
Valter Cussatfor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K021126 |
| Device Name: | EVER STICK ORTHO |
Indications for Use:
GLASS-FIBER REINFORCEMENT FOR
ORTH-DONTIC RETAINERS
(PLEASE DO NOT WRITE BFLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Susan Runnes
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.108) OR
Over the Counter Use _