(40 days)
Not Found
Not Found
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 composite restorations, used for bonding and sealing. This function is restorative and assistive in a dental procedure, rather than directly treating a disease, injury, or condition in a therapeutic manner.
No
The device is described as an adhesive used in dental restorative techniques, performing functions like bonding and sealing. It does not mention any role in identifying or characterizing diseases or medical conditions.
No
The device description is not found, but the intended use clearly describes 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 describes a dental adhesive used for bonding composite restorations to tooth tissue and sealing root surfaces. This is a direct application to the patient's body (in vivo) for a restorative purpose.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
The device is a dental material used in a clinical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces. Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth tissue, exposed root surfaces, enamel, dentin, cavity wall
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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
NOV 1 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bernard van Duijn Manqing Technical Services Cavex Holland BV Harmenjansweq 19-21 P.O. Box 852 2003 RW Haarlem (Holland)
Re : K983545 Quadrant UniBond Trade Name: Requlatory Class: II Product Code: KLE October 6, 1998 Dated: October 9, 1998 Received:
Dear Mr. van Duijn:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Van Duijn
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your alone of your device to a legally Finding of subbeaneral squareults in a classification for your marketca predicatoremits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriation 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 premation on your responsibilities under the Act may be Intoimation of Journall Manufacturers Assistance obcation from one (800) 638-2041 or (301) 443-6597 or at at its coll free namber (0:1)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Direct Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) NUMBER (IF KNOWN) :
DEVICE NAME: Quadrant UniBond
INDICATIONS FOR USE:
Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces.
Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.
(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 Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983545