(45 days)
Not Found
No
The summary describes a chemical bonding agent and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
Explanation: This device is an orthodontic band cement used for bonding, which is a structural material application rather than a direct therapeutic intervention. It helps in the mechanical attachment of orthodontic bands but does not treat a disease or condition itself.
No
Explanation: The device is described as an orthodontic band cement used for bonding, not for diagnosing any condition.
No
The device description clearly states it is a "light-cure two-part system: an orthodontic cement and a primer," which are physical materials, not software.
Based on the provided information, this device 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.
- Device Description and Intended Use: The description clearly states the device is an "ORTHODONTIC BAND CEMENT" used for "Bonding of orthodontic bands to natural and artificial tooth surfaces." This is a direct application to the tooth surface for a mechanical purpose (bonding), not a test performed on a sample taken from the body.
Therefore, the IDEAL® 1 ORTHODONTIC BAND CEMENT falls under the category of a dental device used for restorative or orthodontic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IDEAL® 1 ORTHODONTIC BAND CEMENT is indicated for bonding of orthodontic bands to natural and artificial tooth surfaces.
Product codes
DYH
Device Description
The IDEAL® 1 ORTHODONTIC BAND CEMENT is a light-cure two-part system: an orthodontic cement and a primer. A tooth conditioner is available if desired for the highest stress bonding cases. The cement is packaged in syringes. No mixing is necessary. The primer is packaged in unit dose, self-dispensing capsules.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth surfaces (natural and artificial)
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
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.
0
APR - 2 2004
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York. PA 17405-087 ww dentsniv.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
February 11, 2004 DATE PREPARED:
TRADE OR PROPRIETARY NAME: IDEAL® 1 ORTHODONTIC BAND CEMENT
Bracket adhesive and tooth conditioner resin (872.3750) CL ASSIFICATION NAME:
Ideal® 1 Orthodontic Bracket Adhesive K033703 PREDICATE DEVICES:
The IDEAL® 1 ORTHODONTIC BAND CEMENT is a light-cure DI VICE DESCRIPTION: two-part system: an orthodontic cement and a primer. A tooth conditioner is available if desired for the highest stress bonding cases.
The cement is packaged in syringes. No mixing is necessary. The primer is packaged in unit do se, self-dispensing capsules.
The IDEAL® 1 ORTHODONTIC BAND CEMENT is indicated for INTENDED USE: bo iding of orthodontic bands to natural and artificial tooth surfaces.
TE CHNOLOGICAL CHARACTERISTICS: All of the components found in the IDEAL® l OI:THODONTIC BAND CEMENT have been used in legally marketed devices.
We believe that the prior use of the components of the IDEAL® 1 ORTHODONTIC BAND CEMENT in legally marketed devices, the performance data provided, and the similarity of the prodicate to the new device support the safety and effectiveness of the IDEAL® 1 OILTHODONTIC BAND CEMENT for the intended uses.
t i
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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.
APR = 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance & Regulatory Affairs World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405-0872
Re: K040375
Trade/Device Name: IDEAL®1 Orthodontic Band Cement Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: February 11, 2004 Received: February 17, 2004
Dear Mr. Lehn:
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. Lehn
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 vour 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) 594-56. 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.
Chris Liu, Ph.D.
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
(As Required by 21 CFR 807.87(e)
5040375 51((K) Number (if known):
IDEAL® 1 ORTHODONTIC BAND CEMENT De vice Name:
Indications for Use:
Bonding of orthodontic bands to natural and artificial tooth surfaces
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(I LEASE DO NOT WRITE BELOW THIS LINE --- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: J