(101 days)
Not Found
Not Found
No
The description focuses on the chemical properties and application of a dental bonding material, with no mention of AI or ML.
No.
The device is described as an etch and prime material used for bonding, not for treating a disease or condition.
No
The device is described as an etch and prime material for bonding, not for diagnosing a condition or disease.
No
The device description clearly indicates that Bosworth Bond is a physical material (etch and prime) used in dentistry, not a software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that Bosworth Bond is applied directly to the tooth enamel, which is part of the human body, not a specimen derived from it for examination.
- IVDs are used to provide information for diagnostic, monitoring, or compatibility purposes. Bosworth Bond is used for etching and bonding tooth enamel, which is a therapeutic or restorative procedure, not a diagnostic one.
The description focuses on the material's properties and how it's used in a dental procedure, not on analyzing biological samples to gain diagnostic information.
N/A
Intended Use / Indications for Use
Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.
Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. If the tooth enamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
Bosworth Bond is an all-in-one 2-component etch and prime material. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond. Dye-free 1- or 2-component versions are available; they do not change color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth enamel
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K043170
Trade/Device Name: Bosworth Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 17, 2005 Received: February 18, 2005
Dear Ms. Goldstein:
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 -- Ms. Mildred M. Goldstein
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA S Issualice of a substition with other requirements of the Act or that FDA nas made a determination mar your as a read to vother Federal agencies. You must comply with any Federal statures and regulations administered by 10: registration and listing (21 CFR Part 807); all the Act s requirements, including, but not interest requirements as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing practice requirements as set labeling (21 CFR Part 801), good manazation of applicable, the electronic product radiation Systems (QD) regarders 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) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nothication. "The IDA midning of backannal requence 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 If you desire specific advice 101 your as (240) 276-0115. Also, please note the regulation entitled, Comact the Office of Comphanes at (210) of CFR Part 807.97). You may obtain other Misoranting of reference to promaibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Clats
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
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Page 1 of 1
510(K) Number: _K043170
Device Name: Bosworth Bond
INDICATIONS FOR USE:
Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.
Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-the-Counter Use (Optional Format 1/2/96)
Siva Kumar
Sian-Off Crision of Anesthesiology, General Hospital, Chection Control, Dental Devices
Number: K043170