(72 days)
Not Found
No
The summary describes a dental adhesive and does not mention any AI or ML components or functionalities.
No
The device is described as a dental adhesive for bonding restorative materials, which functions to physically attach materials rather than to treat or cure a disease or condition therapeutically.
No
The device, XENO® III DENTAL ADHESIVE, is described as a dental adhesive for bonding restorative materials, which is a therapeutic function, not a diagnostic one. Its intended use focuses on aiding in the restoration of teeth rather than identifying a medical condition.
No
The device description clearly identifies it as a dental adhesive, which 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 is "as a dental adhesive for direct light-cured composite restorative materials." This describes a material used in the mouth for dental restoration, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description reinforces this, stating it's a "single step self-etching dental adhesive designed to bond direct light-cured composite restorative materials to enamel and dentin." This is a material used for bonding within the oral cavity.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
Therefore, XENO® III DENTAL ADHESIVE is a dental material used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
XENO® III DENTAL ADHESIVE is indicated as a dental adhesive for dire ct light-cured composite restorative materials.
Product codes
KLE
Device Description
XENO® III DENTAL ADHESIVE is a single step self-etching den al adhesive designed to bond direct light-cured composite restorative materials to enamel and dentin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin
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)
XENO® III DENTAL ADHESIVE was evaluated for biocompatibility and found acceptable.
The prior use of the components of XENO® III DENTAL ADHESIVE in legally marketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® III DENTAL ADHESIVE for the indicated uses.
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
§ 872.3200 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
510(k) SUMMARY
JAN 2 3 2003
DENSFLY
NAME & ADDRESS:
est College Avenue PA 17405-087
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
November 11, 2002 DATE PREPARED:
TRADE OR PROPRIETARY NAME: XENO® III DENTAL ADHESIVE
CLA SSIFICATION NAME: Resin tooth bonding agent (872.3200)
Prime & Bond™ NTTM Nano-Technology PREDICATE DEVICES: K982394 Light Cured Dental Adhesive
XENO® III DENTAL ADHESIVE is a single step self-etching DE'/ICE DESCRIPTION: den al adhesive designed to bond direct light-cured composite restorative materials to enamel and dentin.
INTENDED USE: XENO® III DENTAL ADHESIVE is indicated as a dental adhesive for dire ct light-cured composite restorative materials.
TE CHNCLOGICAL CHARACTERISTICS: All of the components found in XENO® III DENTAL ADHESIVE have been used in marketed devices or have been found to be safe for der tal use.
XE NO® III DENTAL ADHESIVE was evaluated for biocompatibility and found acceptable.
W : believe that the prior use of the components of XENO® III DENTAL ADHESIVE in legally mr rketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® III DENTAL ADHESIVE for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
JAN 2 3 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
·Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17404
Re: K023776
Trade/Device Name: Xeno III Dental Adhesive Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 11, 2002 Received: November 12, 2002
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 your 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) 594-4618. 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,
Susan Runoey
Susan Runner, DDS, MA Interim 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)
51C(K) Number (if known): K₀ 23 7.76
XENO® III DENTAL ADHESIVE Device Name:
Indications for Use:
Dental adhesive for direct light-cured composite restorative materials
(P) EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| OR |
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Kevin Mulvey for MSR
nesthesiology, General Hospital, Infection Control, Dental D
510(k) Number.________________________________________________________________________________________________________________________________________________________________