(77 days)
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Not Found
No
The summary describes a dental adhesive and does not mention any AI/ML related terms or functionalities.
No
The device is a bonding agent for composites and compomers, which is a material used in dental restoration, not a device used for treating disease or injury.
No
Explanation: The device, ADHESIVE 14, is intended as a bonding agent for composites to dentine tooth structure. Its function is to join materials, not to identify or determine the nature of a disease or condition.
No
The device is described as a "bonding agent" for dental composites, 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 is to bond dental materials (composites and compomers) to tooth structure (dentine). This is a direct application to the patient's body for a restorative purpose.
- Anatomical Site: The anatomical site is "dentine tooth structure," which is part of the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body) to provide diagnostic information about a patient's health. IVDs typically involve testing blood, urine, tissue samples, etc., to detect diseases, conditions, or markers.
This device appears to be a dental restorative material used directly on the patient during a dental procedure.
N/A
Intended Use / Indications for Use
ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure.
Contraindications: The placement of Adhesive 14 is contraindicated if the patient is known to be allergic to the components of Adhesive 14.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
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
Tooth structure (dentine)
Indicated Patient Age Range
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Intended User / Care Setting
Dental professional such as DDS or DMD.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
ood and Drug Administratio 0 Corporate Boulevard ockville MD 20850
NOV 22 2002
AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260
Re: K022973 Trade/Device Name: Adhesive 14 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. Ingersoll:
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 -- Mr. Ingersoll
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours,
Thomae Ciminati, S.J.
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
AB ARDENT
Generatorgatan 8 S. 195 60 Marsta S vederi +046 8 591 210 20 Phone . +046 8 591 161 83 FX
510 (k) ADHESIVE 14 ATTACHMENT #4
INDICATIONS FOR USE
Indications:
A DHESIVE 14 is to be used as a bonding agent for light curing composites and c >mpomers to dentine tooth structure.
( ontra indications:
7 he placement of Adhesive 14 is contraindicated if the patient is known to be allergic to the cornponents of Adhesive 14.
F or use only by dental professional such as DDS or DMD. Not for use by general rublic or OTC.
Viticu Lucende for S. Pierce
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022773