(184 days)
Not Found
No
The summary describes a dental composite material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is used for tooth filling, which is a therapeutic intervention to treat dental caries or other tooth damage.
No
The device is described as a flowable composite for tooth filling, sealing, and cementing, which are treatment procedures, not diagnostic ones.
No
The device description clearly indicates it is a physical material (flowable composite) used for tooth filling, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tooth filling, sealing and cementing." This is a direct treatment or restoration of a physical structure (a tooth) within the body.
- Device Description: The description focuses on the physical properties of the material (flowable, aesthetic, abrasion resistant, etc.) and its application in dentistry.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to analyze things like blood, urine, tissue samples, etc.
This device is a dental restorative material, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
For anterior and limited posterior restorations and sealings in dentistry
A flowable light cure microhybrid composite for tooth filling, sealing and cementing.
Product codes
EBF
Device Description
Stick™ Flow is a flowable composite with excellent color stability. It is flowable, aesthetic, abrasion resistant, strongly radiopaque and high gloss polish able.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / Dental
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
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
OCT 2 9 2003
E. 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: | April 16th, 2003 |
| Device Trade Name: | Stick™ Flow |
| Device Common Name: | Flowable light cure composite |
| Device Classification Name: | Material, tooth shade and resin |
| (21 CFR §872.3690) |
Description of Device:
Stick™ Flow is a flowable composite with excellent color stability. It is flowable, aesthetic, abrasion resistant, strongly radiopaque and high gloss polish able.
Intended Use: For anterior and limited posterior restorations and sealings in dentistry
Stick™ Flow is substantially equivalent to Aeliteflo™, approved under 510(k) number K955292 dated December 13, 1995.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three wavy lines, which are meant to represent a human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Stick Tech Limited C/O William M. Troetal, Ph.D. LLC Managing Partner William M. Troetel, LLC 80 Parkwav West Mount Vernon, New York 10552
Re: K031341
Trade/Device Name: Stick Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 8 , 2003 Received: August 11, 2003
Dear Mr. Troetal:
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.
2
Page 2 -Mr. 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 (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), 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,
Ques
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 B.
5 · 0(k) Number (if known): _ K (31341
Device Name: Stick™ Flow
Indications for Use:
- A flowable light cure microhybrid composite for tooth filling, sealing and . cementing.
Kein Mulay for MSR
(Divisi Division of Anesthesiology, General Ho on Control. Dental D
510(k) Number
(FLEASE 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)