(70 days)
Not Found
Not Found
No
The device description and intended use clearly describe a physical material and accessories used in a manual process (heating and vacuum-forming) by a practitioner. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is described as "flat sheets of thermoplastic" used for "fabrication of orthodontic and dental appliances." It is a material for manufacturing appliances, not an active therapeutic device itself.
No
The device is used for the fabrication of orthodontic and dental appliances, not for diagnosing medical conditions. It is a material that is shaped over a dental impression.
No
The device description clearly states it is a physical sheet of thermoplastic material and injection-molded accessories, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication of orthodontic and dental appliances." This is a mechanical process for creating physical devices used in the mouth.
- Device Description: The description details a process of heating and vacuum-forming thermoplastic sheets over a dental impression. This is a manufacturing process, not a diagnostic test.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Thermoform Sheet Materials and Accessories are indicated for the fabrication of orthodontic and dental appliances.
Product codes
NXC, MQC
Device Description
Thermoform Sheet Materials are flat sheets of thermoplastic. The sheets are heated by the practitioner and then vacuum-formed over a dental impression of the patient's teeth. The sheet is then trimmed to fit. The Accessories are sheet material formulations manufactured by injection molding.
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
072522
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis | NOV 1 6 2007 | |
|---|---|---|---|
| DATE PREPARED: | SEP 0 6 2007 | ||
| TRADE OR PROPRIETARY NAME: | THERMOFORM SHEET MATERIALS AND ACCESSORIES | ||
| CLASSIFICATION NAME: | Sequential Aligner | ||
| Mouthguard | NXC | ||
| MQC | 872.5470 | ||
| Unclassified |
DEVICE DESCRIPTION: Thermoform Sheet Materials are flat sheets of thermoplastic. The sheets are heated by the practitioner and then vacuum-formed over a dental impression of the patient's teeth. The sheet is then trimmed to fit. The Accessories are sheet material formulations manufactured by injection molding.
Mouthguard and Aligner Materials
INTENDED USE: Thermoform Sheet Materials and Accessories are indicated for the fabrication of orthodontic and dental appliances.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in Thermoform Materials and Accessories have been used in legally marketed devices and/or were found safe for dental use. Appropriate biocompatibility testing has been completed.
We believe that the prior use of the components of Thermoform Sheet Materials and Accessories in legally marketed devices and the biocompatibility data provided support the safety and effectiveness of Thermoform Sheet Materials and Accessories for the indicated uses.
000011
PREDICATE DEVICES:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human figures. The figures are connected and represent the health and well-being of individuals and families. The seal is in black and white.
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K072522
Trade/Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: September 6, 2007 Received: September 7, 2007
Dear Ms. Lewis:
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 - Ms. Lewis
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours.
Mitfor Ogl
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 STATEMENT
510(k) Number (if known):
THERMOFORM SHEET MATERIALS AND ACCESSORIES Device Name:
Indications for Use:
THERMOFORM SHEET MATERIALS AND ACCESSORIES are indicated for the fabrication of orthodontic and dental appliances.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suor Kuarez
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K072522