(68 days)
Not Found
No
The summary describes materials used to fabricate dental appliances and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as materials for fabricating orthodontic and dental appliances, not the therapeutic appliance itself. The intended use focuses on the fabrication of devices by dental professionals, which are then used therapeutically.
No
The device is a material for fabricating dental and orthodontic appliances. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description explicitly states the device is "plastic, resin, or laminate materials" used for fabrication, 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 is for the fabrication of various dental and orthodontic appliances that are used in the mouth (e.g., aligners, mouthguards, splints). This is a physical application within the body, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details plastic, resin, or laminate materials used for creating physical devices. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
The device is clearly intended for the creation of physical dental appliances for therapeutic or protective purposes.
N/A
Intended Use / Indications for Use
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances.
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
Product codes (comma separated list FDA assigned to the subject device)
MQC, EBG, NXC, KMY
Device Description
MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose of making various dental and/or orthodontic appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges. Each material is indicated for the fabrication of orthodontic and dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the sheets are thermoformed and trimmed to create custom devices or appliances.
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
N/A
0
NOV 2 7 2006
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | September 13, 2006 |
| TRADE OR PROPRIETARY NAME: | MOUTHGUARD AND ALIGNER MATERIALS |
| CLASSIFICATION NAME: | Mouthguard, Unclassified |
| Orthodontic plastic bracket, 872.5470 | |
| PREDICATE DEVICES: | The Doctor's® NightGuard TM , K053580 |
| EZ Splint / EZ Splint PM, K022809 | |
| Align System, K981095 |
DEVICE DESCRIPTION:
MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose of making various dental and/or orthodontic appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges. Each material is indicated for the fabrication of orthodontic and dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the sheets are thermoformed and trimmed to create custom devices or appliances.
INTENDED USE:
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances.
TECHNOLOGICAL CHARACTERISTICS:
The MOUTHGUARD AND ALIGNER MATERIALS are used in customized devices. All of the components found in MOUTHGUARD AND ALIGNER MATERIALS have been used in legally marketed devices or have been determined safe for dental use. We believe that the prior use of the components in legally marketed devices and the data provided support the safety and effectiveness of MOUTHGUARD AND ALIGNER MATERIALS for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2006
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K062828
Trade/Device Name: Mouthguard and Aligner Materials Regulation Number: None Regulation Name: Mouthguard Regulatory Class: Unclassified Product Codes: MQC, EBG, NXC, KMY Dated: November 16, 2006 Received: November 20, 2006
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. Helen 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Sylette Y. Michael and.
Chiu S. Lin, PhD 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
510(K) Number (if known):
MOUTHGUARD AND ALIGNER MATERIALS Device Name:
Indications for Use:
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
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)
R.Betz DMS for Dr. Susan Kummer
Anesthesiology, General Hospital,
Pain Control, Dental Devices
Premarket Notification
MOUTHGUARD AND ALIGNER MATERIALS