(92 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics related to algorithmic analysis indicate no AI/ML is incorporated.
No
The device is described as a semi-manufactured product for periodontal splinting, which is a supportive rather than a therapeutic function. It's a material used in a procedure, not a device that directly administers therapy.
No
The device is described as a product for "periodontal splinting," indicating it is used for treatment (stabilizing teeth) rather than for diagnosing a condition.
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 product, 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 periodontal splinting." This is a clinical procedure performed directly on a patient's teeth and gums.
- Device Description: The device is described as a "semi-manufactured product made of glass fibers and polymer/resin matrix" used for splinting. This is a material used in a dental procedure, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
For periodontal splinting
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
everStick™ PERIO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ PERIO 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.
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
F-1
| F. 510(k) Summary | |
|---|---|
| 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: | December 17, 2002 |
| Device Trade Name: | everStick™ PERIO |
| Device Common Name: | Glass fiber periodontal splint |
| Device Classificaton Name: | Denture relining, repairing, or rebasing resin |
| (21 CFR §872.3760) |
Description of Device:
everStick™ PERIO is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick™ PERIO is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.
Intended Use: For periodontal splinting
everStick™ PERIO is substantially equivalent to everStick™, approved under 510(k) number K011788 dated November 7, 2001.
The composition of everStick™ PERIO is equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different.
1
By comparing the ingredients of everStick PERIO to the existing data available from dental polymerizable material, it can be stated that everStick PERIO does not expose the dentist nor the patient to unacceptable risks.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three wavy lines representing the body, head, and arms. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Stick Tech Limited C/O Dr. William Troetel William M. Troetel, LLC 80 Parkway West Mount Vernon, New York 10552
Re: K030072
Trade/Device Name: everStick™ PERIO Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: 76 EBI Dated: April 4, 2003 Received: April 7, 2003
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 vour 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.
3
Page 2 – Dr. Troetel
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. You must comply 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 requirements as set forth in the quality systems (OS) 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), please contact the Office of Compliance at (301) 594-4613. 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 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.
Susan Burns
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement B.
K030072 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: everStick™PERIO
Indications for Use:
- · For periodontal splinting.
Ken-Maly for MIR
ion Sign-Off (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices
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)
OR
Over-the-Counter Use
(Optional Format 1-2-96)