(150 days)
Not Found
No
The description focuses on the material composition and mechanical properties of a fiberglass reinforcement product for dental applications. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The device is used for reinforcing dental and orthodontic appliances and splints, not for directly treating a disease or condition.
No
The device is described as a reinforcement material for dental prosthetics and splints, and its intended use does not involve diagnosing medical conditions or diseases.
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 clearly describes the device as a reinforcement material for dental appliances (dentures, crowns, bridges, splints). This is a structural and mechanical function within the mouth, not a diagnostic test performed on samples taken from the body.
- Device Description: The description confirms it's a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylics. This aligns with its structural purpose.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
Therefore, based on the provided text, everStickNet™ is a dental material used for reinforcement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- As reinforcement in manufacturing and/or repairing full or partial dentures as . well as overdentures and orthodontic appliances.
- As reinforcement for temporary and/or permanent plastic/composite partial . and full crowns and bridges.
- As reinforcement for customized splints used to immobilize teeth which may . be required for post-trauma, post-operative, or orthodontic therapy.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
everStickNet™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStickNet™ is made of a thin fiberglass fabric, which increase the strength and stiffness of the final product in all directions.
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)
Test results indicate that there are no hazards presented with the use of everStickNet™ as compared with the predicate device.
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.
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
NOV 0 5 2001
F. 510(k) Summary
| Applicant: | Stick Tech Ltd, PO Box 114, 20521 Turku, Finland |
|---|---|
| Tel: +358-2-4808 2500 | |
| Fax: +358-2-241 0032 | |
| Contact Person: | Ilkka Kangasniemi, 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: | June 4th, 2001 |
| Device Trade Name: | everStickNetTM |
| Device Common Name : | Glass fiber reinforcement material |
| Device Classificaton Name: | Denture relining, repairing, or rebasing resin |
| (21 CFR §872.3760) |
Description of Device:
everStickNet™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStickNet™ is made of a thin fiberglass fabric, which increase the strength and stiffness of the final product in all directions.
Intended Use:
As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances.
As reinforcement for temporary and/or permanent plastic/composite partial and full crowns and bridges.
As reinforcement for customized splints used to immobilize teeth which may be required post-trauma, post-operative, or for orthodontic therapy.
1
everStickNet™ is substantially equivalent to fibreNet™, approved under 510(k) number K003334 dated January 8, 2001.
Testing which has been performed on everStickNet™ indicates that the device has the same intended use but somewhat different technological characteristics.
everStickNet™ is a polymer impregnated bi-directionally continuously woven glass fiber whereas fibreNet™ is a polymer pre-impregnated bi-directionally woven glass fiber. The different technological characteristics of everStickNet™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device.
Test results indicate that there are no hazards presented with the use of everStickNet™ as compared with the predicate device.
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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stick Tech Limited NOV 0 5 2001 C/O Dr. William Troetel Managing Partner William M. Troetel, LLC 80 Parkway West Mount Vernon, New York 10552
Re: K011799
Trade/Device Name: Eversticknet Regulation Number: 872.3760 Regulation Name: EBI Resin, Denture, Relining, Repairing, Rebasing Regulatory Class: II Product Code: EBI Dated: October 29, 2001 Received: October 30, 2001
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 controls provisions 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 12) is and 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
3
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and Nyanments, including, but not limited to: registration 1 ou must comply with and the reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 807), absitisg (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality in 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 anow you to oegalling of substantial equivalence of your device to 310(k) promative nouricate 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 II you desire specific ad 1.00 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Collightance are, 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 notification (21 OF ICP of the Division of Small Manufacturers, International and the Act may be obtained in 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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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B-1
NOV 0 5 2001
B. Indications for Use
510(k) Number (if known): \