(92 days)
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No
The provided text describes a dental bonding agent and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a bonding agent for dental restorations, which is a material used to prepare a surface for treatment rather than to treat a condition itself.
No
Explanation: The device is described as a self-cure bonding agent for dentin and enamel, applied as a thin coating to tooth surfaces for use with composite resins. This indicates a therapeutic or restorative function, not a diagnostic one.
No
The provided text describes a bonding agent, which is a physical substance, 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 a bonding agent applied to tooth surfaces (dentin and enamel) for use with composite resins. This is a direct application to the patient's body for a dental procedure.
- Anatomical Site: The anatomical sites mentioned are "dentin and enamel," "tooth surfaces," and "tooth structure." These are all parts of the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a physiological state, health, or disease.
Therefore, based on the provided text, ENCORE BOND is a dental material used directly on the patient's teeth, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ENCORE BOND is a self-cure bonding agent for dentin and enamel and the considering is and applied in a thin coating to ENCORE BOND is a self-cure bonding agains a thin coating to tooth surfaces. It is mixed and apprica in a case of the composite resins to tooth structure.
Product codes
KLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Dentin and enamel / tooth surfaces / tooth structure
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right, representing service to the people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Discko ·Executive Vice President Centrix Incorporated 770 River Road Shelton, Connecticut 06484-5458
JUN 27 1997
K971121 Re : Encore Bond Trade Name: Regulatory Class: II Product Code: KLE Dated: April 24, 1997 Received: April 29, 1997
Dear Mr. Discko:
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, listing 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸਾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Discko
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
U. Uhlstrist
A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
of Page_
| 510(k) Number (if known): | K971121 |
|---|---|
| Device Name: | ENCORE BOND |
Indications For Use: ... . . . . . .........
ENCORE BOND is a self-cure bonding agent for dentin and enamel
and the considering is and applied in a thin coating to ENCORE BOND is a self-cure bonding agains a thin coating to tooth surfaces. It is mixed and apprica in a case of the composite resins to tooth structure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Rumper
(Division Sign-Off) (Division of Dental, Infection Control, Divisioneral Hospital Da 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use No
(Optional Format 1-2-96)