(27 days)
XENO® NM Light Cured Dental Adhesive is indicated for:
- Direct composite and compomer restorations for all cavity classes in anterior and posterior teeth
- Veneers
- Composite, ceramic and metal repairs
- Cavity varnish for use with fresh amalgam
The XENO® NM Light Cured Dental Adhesive is a one-component light cure self-etching and self-priming dental adhesive designed to bond composite materials and compomers to enamel and dentin as well as to metals and ceramic. XENO® NM Light Cured Dental Adhesive combines acid etching, priming and adhesive in a single bottle.
The XENO® NM Light Cured Dental Adhesive did not conduct a separate study with acceptance criteria and device performance as it is a predicate device. The information provided describes the device's characteristics and its substantial equivalence to previously marketed devices.
However, based on the provided text, we can infer some aspects related to its technological characteristics and the grounds for its acceptance.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a predicate device applying for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) against a predefined threshold are not explicitly stated for this 510(k) submission. Instead, the "acceptance" is based on its similarity to legally marketed predicate devices and established safety through biocompatibility testing.
| Acceptance Criteria (Inferred from 510(k) summary) | Reported Device Performance (Inferred from 510(k) summary) |
|---|---|
| Technological Characteristics: All components present in the device have been used in legally marketed devices. | All components found in XENO® NM Light Cured Dental Adhesive have been used in legally marketed devices. |
| Biocompatibility: Device found acceptable for genotoxicity, cytotoxicity, and sensitivity. | XENO® NM Light Cured Dental Adhesive final formulation was evaluated for biocompatibility for genotoxicity, cytotoxicity, and sensitivity and found acceptable. |
| Safety and Effectiveness: Supported by prior use of components, biocompatibility data, and performance data for indicated uses. | "We believe that the prior use of the components of XENO® NM Light Cured Dental Adhesive in legally marketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® NM Light Cured Dental Adhesive for the indicated uses." |
| Intended Use: Consistent with predicate devices. | Intended uses are for direct composite and compomer restorations, veneers, composite/ceramic/metal repairs, and cavity varnish for fresh amalgam. These are consistent with those of similar dental adhesives. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The submission focuses on the composition of the adhesive and its biocompatibility, rather than clinical performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided as a formal clinical study with ground truth established by experts was not detailed in this submission. The "ground truth" for the acceptance of the device's design and materials comes from prior regulatory approvals of similar components and the results of biocompatibility testing interpreted by qualified personnel (though not explicitly named or quantified).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As no detailed clinical test set is described, there's no mention of an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as the device is a dental adhesive, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance comparison would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a dental adhesive, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance is based on:
- Prior regulatory approval/history of components: The fact that all components have been used in legally marketed devices serves as a form of "ground truth" for material safety and efficacy in dental applications.
- Biocompatibility testing results: The device underwent standard genotoxicity, cytotoxicity, and sensitivity testing, with "acceptable" results serving as the ground truth for biological safety.
8. The sample size for the training set:
This information is not provided. As this is not an AI/machine learning device, there wouldn't be a "training set" in that context. The "training" for the device's design and development comes from existing knowledge of dental materials and their performance.
9. How the ground truth for the training set was established:
This information is not provided. Similar to point 8, the concept of a training set and its ground truth in the context of AI/machine learning does not apply to this type of medical device. The "ground truth" for its development is based on established dental material science and regulatory precedents.
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1041343
510(k) SUMMARY
JUN 1 6 2004
DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, PA 17405-0872 P. J. Lehn Telefax (717) 849-4343
XENO® NM Light Cured Dental Adhesive
P. Jeffery Lehn CONTACT:
May 17, 2004 DATE PREPARED:
TRADE OR PROPRIETARY NAME:
Resin tooth bonding agent (872.3200) CLASSIFICATION NAME:
Prime & Bond® NT™ Nano-Technology Light Cured PREDICATE DEVICES: K982394 Dental Adhesive
DEVICE DESCRIPTION:
The XENO® NM Light Cured Dental Adhesive is a one-component light cure self-etching and self-priming dental adhesive designed to bond composite materials and compomers to enamel and dentin as well as to metals and ceramic.
XENO® NM Light Cured Dental Adhesive combines acid etching, priming and adhesive in a single bottle.
INTENDED USE:
- Direct composite and compomer restorations. .
- . Veneer
- Composite, ceramic and metal repairs. ●
- Cavity varnish for use with fresh amalgam .
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in XENO® NM Light Cured Dental Adhesive have been used in legally marketed devices.
XENO® NM Light Cured Dental Adhesive final formulation was evaluated for biocompatibility for genotoxicity, cytotoxicity, and sensitivity and found acceptable.
We believe that the prior use of the components of XENO® NM Light Cured Dental Adhesive in legally marketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® NM Light Cured Dental Adhesive for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2004
Dentsply International Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404-0872
Re: K041343
Trade/Device Name: XENO® NM Light Cured Dental Adhesive Regulation Number: 872.3200 Regulation Name: Resin tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: May 17, 2004 Received: May 20, 2004
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 referenced above and have acterinatiosure) 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 Amendinens, of to actived acosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confors providens of an 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 II your device is classified (bood additional controls. Existing major regulations affecting (1 Nr.), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in ther announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on that your device complies with other requirements mean that FDA nas made a decornmances wating administered by other Federal agencies. of the Act of ally I cucral statutes and regulations, but not limited to: registration You must colliply with an the Act b requirement 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED (21 CFR Part 800); and and listing (21 CFR Purt 007), laceling (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bjections (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) This letter will anow you to begin mailering your substantial equivalence of your device to a premarket notification. The PDF Intelligence and the 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), If you desire specific advice for your de at (301) 594-4613. Also, please note the regulation prease contact une Other or Somplians premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Diviser (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ke Muluy
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
| 510(K) Number (if known): | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
XENO® NM Light Cured Dental Adhesive Device Name:
Indications for Use:
XENO® NM Light Cured Dental Adhesive is indicated for:
- Direct composite and compomer restorations for all cavity classes in anterior and posterior . teeth
- Veneers .
- Composite, ceramic and metal repairs ●
- Cavity varnish for use with fresh amalgam .
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rupp
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number: Kal 1343
§ 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.