(184 days)
Not Found
Not Found
No
The summary describes a physical composite material used for fabricating dental splints and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used for "producing functional therapy and bite splints," indicating its role in providing therapy.
No
The device is described as a material used for producing functional therapy and bite splints, not for identifying diseases or conditions. Its purpose is fabrication, not diagnosis.
No
The device description explicitly states it is a "light composite" and is "fabricated outside of the mouth from stone models," indicating it is a physical material, not software.
Based on the provided information, the Primosplint System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Primosplint's Function: The description clearly states that the Primosplint System is used for producing functional therapy and bite splints. These are devices fabricated outside of the mouth from stone models and used in the mouth for therapeutic purposes. They do not involve testing biological samples.
Therefore, the Primosplint System falls under the category of a dental device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Use for: Primosplint System should be used for producing functional therapy and bite splints.
Product codes
MQC
Device Description
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
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.
Not Found
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
N/A
0
Image /page/0/Picture/1 description: The image shows a circular logo with the words "PUBLIC HEALTH SERVICE" written around the top half of the circle and "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the bottom half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2003
Mr. Michael O` Malley President Cosmedent Company Incorporated 401 North Michigan Avenue Suite 2500 Chicago, Illinois 60611
Re: K030832
Trade/Device Name: Primosplint System Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: MQC Dated: June 30, 2003 Received: July 1, 2003
Dear Mr. O' Malley:
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.
1
Page 2 -Mr. O' Malley
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,
Susan Kunnen
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
2
COSMEDENT®
INDICATIONS FOR USE STATEMENT
510(kK) Number (if known):
…
Device Name:
Primosplint System
Indication for Use:
Use for:
Primosplint System should be used for producing functional therapy and bite splints.
DESCRIPTION OF DEVICE
Primosplint is a light composite developed for functional therapy bite splints and other applications. It is fabricated outside of the mouth from stone models. It may be polished mechanically or by the use of a glaze.
A confidential chemical analysis of Primosplint System may be found in Rein Maly SachSR Appendix B.
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K030832 |
|---|---|
| ---------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the Counter Use