(85 days)
No
The summary describes a dental bonding agent and does not mention any AI or ML capabilities.
No
The device is described as an adhesive for dental materials and not for treating or preventing a disease or condition.
No
The device is described as an adhesive and bonding agent for dental materials, not for diagnosing medical conditions. Its intended use is for adhesion and bonding of filling materials, not for diagnostic purposes.
No
The device description clearly states it contains chemical components (Alcohol and Acetone) and is used for adhesion and bonding, 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 describes the device's function in bonding dental materials to teeth and other restorative materials. This is a direct application within the patient's mouth (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description details the chemical composition and properties related to its bonding function.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device's function is purely restorative and adhesive within the oral cavity.
N/A
Intended Use / Indications for Use
Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Product codes
KLE
Device Description
Bond 1 C&B contains Alcohol and Bond 1 K973388 contains Acetone. Bond 1 C&B will reduce the technique sensitivity of bonding, increasing the working time and decreasing the potential for sensitivity. However, some dentists prefer to use either Acetone or Alcohol. The safety and effectiveness is not affected due to Alcohol being used in Bond 1 C&B instead of Acetone, which Bond 1 contains. This will reduce the technique sensitivity bonding, increasing the working time and decreasing the potential for sensitivity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin, 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
No clinical performance investigations were conducted on Bond 1 C & B since it is substantially equivalent to Bond 1, K973388. Cytoxicity studies will be furnished upon request. Materials in Bond 1 C&B are known in the industry.
Key Metrics
Not Found
Predicate Device(s)
Bond 1, K973388
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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MAR 2 1 2000
Image /page/0/Picture/1 description: The image shows a sequence of characters in a bold, sans-serif font. The characters appear to be 'K99439q', with some distortion or stylistic variation in the letterforms. The characters are solid black against a white background, creating a high-contrast image.
21.0 510(K) SUMMARY
Jeneric/Pentron, Inc. Submitter: 53 North Plains Industrial Road Address: Wallingford, Connecticut 06492 Contact Tel: 203-265-7397 X619 Contact Fax: 203-265-7662 Contact Person: Annmarie Tenero Date Summary Prepared: March 14, 2000
Bond 1 C&B is substantially equivalent to Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used with other conditions for bonding of composite to metal including, amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Bond 1 C&B contains Alcohol and Bond 1 K973388 contains Acetone. Bond 1 C&B will reduce the technique sensitivity of bonding, increasing the working time and decreasing the potential for sensitivity. However, some dentists prefer to use either Acetone or Alcohol.
The safety and effectiveness is not affected due to Alcohol being used in Bond 1 C&B instead of Acetone, which Bond 1 contains. This will reduce the technique sensitivity bonding, increasing the working time and decreasing the potential for sensitivity.
No clinical performance investigations were conducted on Bond 1 C & B since it is substantially equivalent to Bond 1, K973388. Cytoxicity studies will be furnished upon request. Materials in Bond 1 C&B are known in the industry.
Jeneric/Pentron, Inc. 510(k) Summary - Bond 1 C&B March 14, 2000
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.
MAR 2 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Annmarie Tenero Jeneric®/Pentron® Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724
K994359 Re : Bond 1 C&B Trade Name: Requlatory Class: II Product Code: KLE Dated: March 3, 2000 Received: March 13, 2000
Dear Ms. Tenero:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listinq of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. Tenero
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucentiffer
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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人民网 | 大发快三十分 |
5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN): K994359
DEVICE NAME: BOND 1 C& B
INDICATION FOR USE:
Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
. .
(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) |
| Susan Runne (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | K994359 |
5.0