(150 days)
Not Found
No
The summary describes a material (glass fibers and polymer/resin matrix) used for reinforcement in dental applications. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The testing described focuses on material properties and safety compared to a predicate device.
No
The device is described as a reinforcement material for dental appliances and restorations, not as a device that directly treats a medical condition or disease. Its function is structural support.
No
Explanation: The device description states that EverStick™ is a semi-manufactured product for reinforcing dental acrylic polymers in dentures, orthodontic appliances, and various dental restorations. Its intended use is for structural reinforcement, not for diagnosing medical conditions.
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 and restorations. This is a structural and mechanical function within the mouth, not a diagnostic test performed on biological samples outside the body.
- Device Description: The description details the composition of the device (glass fibers and polymer/resin matrix) and its function as a reinforcement for dental polymers. This aligns with a material used in dental fabrication and repair.
- 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 used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 inlays, . onlays and bridges.
- As reinforcement for customized splints used to immobilize teeth which may . be required post-trauma, post-operative, or for orthodontic therapy.
Product codes
EBI
Device Description
everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase 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
Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics.
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 everStick™ as compared with the predicate device.
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
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
510(k) Summary E.
| Applicant: | Stick Tech Ltd, PO Box 114, 20521 Turku, Finland
Tel: +358-2-4808 2558
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: | everStickTM |
| Device Common Name: | Glass fiber reinforcement material |
| Device Classification Name: | Denture relining, repairing, or rebasing resin
(21 CFR §872.3760) |
Description of Device:
everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase the strength and stiffness of the final product perpendicular to the direction of the fibers.
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 inlays, onlays and bridges.
As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.
1
everStick™ is substantially equivalent to fibreStick™, approved under 510(k) number K003333 dated January 4, 2001.
Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics.
everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber. The different technological characteristics of everStick™ 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 everStick™ as compared with the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 5 2001
Stick Tech Limited C/O Dr. William Troetel Managing Partner William M Troetel, LLC 80 Parkway West Mount Vernon, New York 10552
Re: K011788
Trade/Device Name: Everstick Regulation Number: 872.3760 Regulation Name: EBI Resin, Denture, Relining, Pepairing, 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 your 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
3
Page 2 - Dr. Troetel
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Fet of all - 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 and insting (21 es read of the quality systems (QS) 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 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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
NOV 0 5 2001
B-1
B. Indications for Use
510(k) Number (if known): KOLL788
Device Name: __everStick™
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 inlays, . onlays and bridges.
- As reinforcement for customized splints used to immobilize teeth which may . be required post-trauma, post-operative, or for orthodontic therapy.
Susan Punney
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)