(246 days)
No
The summary describes a physical material (glass fibers and polymer/resin matrix) used for orthodontic splinting and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is described as a semi-manufactured product for orthodontic splinting, which suggests it is a component used to create an orthodontic device rather than a complete therapeutic device itself. Its function of "splinting" indicates it provides support or stabilization, which is a structural rather than an active therapeutic function.
No
Explanation: This device is described as a semi-manufactured product for orthodontic splinting, and its description focuses on its material composition and mechanical properties rather than any diagnostic capability.
No
The device description explicitly 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 "For orthodontic splinting." This is a therapeutic application within the mouth, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a material used for structural support in orthodontics (glass fibers and polymer/resin matrix). This is a physical device, not a reagent or instrument used for analyzing biological samples.
- 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 perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
For orthodontic splinting
Product codes (comma separated list FDA assigned to the subject device)
DYW
Device Description
everStick® A&O is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick® A&O 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): 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.
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.
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
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
MAR 2 ] 2006
510(k) Summary ﻨﺎ
| Applicant: | Stick Tech Ltd, PO Box 114, 20521 Turku, Finland
Tel: +358-2-4808 2552
Fax: +358-2-241 0032 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karri Airola, Ph.D. |
| U.S. Agent to respond to FDA requests: | William M. Troetel, Ph.D.
80 Parkway West
Mount Vernon, NY 10552
Tel: (914) 664-1640
Fax: (914) 667-3993
wtroetel@westnet.com |
| Date Prepared: | January 30, 2006 |
| Device Trade Name: | everStick® A&O |
| Device Common Name: | Glass fiber for orthodontic splinting |
| Device Classificaton Name: | Orthodontic Plastic Bracket
(21 CFR §872.5470) |
Description of Device:
everStick® A&O is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick® A&O is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
For orthodontic splinting Intended Use:
everStick A&O is substantially equivalent to its predicate device Damon 3 (510(K) number K052477) by Ormco Inc. in its clinical use. The composition of everStick® A&O is equal to everStick® PERIO (510(k) number K030072). By comparing the clinical usage of everStick A&O with the plastic bracket Damon 3 and by comparing the ingredients of everStick® A&O to the existing data available from dental polymerizable material, it can be stated that everStick® A&O does not expose the dentist nor the patient to unacceptable risks.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAK 2 J 2006
Stick Tech Limited C/O Dr. William M. Troetel Certified Regulatory Consultant Managing Partner William M. Troetel, LLC 80 Parkway West Mount Vernon, New York 10552
Rc: K051953
Trade/Device Name: everStick® A&O Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Brackct Regulatory Class: II Product Code: DYW Dated: March 7, 2006 Received: March 8, 2006
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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to de reast act (Act) that do not require approval of a premarket the Fouchal application (PMA). You may, therefore, market the device, subject to the general approval applicans of the Act. The general controls provisions of the Act include controls provisions of a 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 If your dovice in elabories to such additional controls. Existing major regulations affecting (1 WA), it may ob subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.
2
Page 2 - Dr. Troetel
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast to advisod that 1992 a determination that your device complies with other requirements mean that I Drimas made a atutes and regulations administered by other Federal agencies. of the Act of ally rederal station and securements, including, but not limited to: registration r ou must comply what are 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 OF R Par 807), acclity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quarty ajon 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) This letter will anon your be FDA finding of substantial equivalence of your device to a prematics notification. - 11 cevice 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), rryou dealte splee of Compliance at (240) 276-0115. 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 may volum 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/industry/support/index.html.
Sincerely yours.
Clur
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 Statement B.
510(k) Number (if known):_K ﮏ۱۹ﮐ >
Device Name: everStick® A&O
Indications for Use:
- . For orthodontic splinting
Susan Cuomo
v, General Hospit
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANQTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)