(93 days)
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Not Found
No
The device description and intended use clearly describe a dental cement, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
No.
The device is a self-adhesive cement for bonding dental restorations, which is a material used in restorative dentistry rather than a device intended for therapy or treatment of a disease or condition.
No
The device is a self-adhesive cement used for bonding dental restorations, a function related to treatment rather than diagnosis.
No
The device description clearly states it is a "self-adhesive cement" and a "gel-like product," indicating it 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 for "bonding of ceramic and composite restorations" to the "dental surface." This is a direct therapeutic or restorative application within the body (specifically, the mouth).
- Device Description: The description details a dental cement used for bonding materials to teeth. It describes its physical properties and how it's used in a dental procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples like blood, urine, tissue, etc., outside of the body to gain information about a person's health status. This device is used directly on the patient's tooth for a restorative purpose.
N/A
Intended Use / Indications for Use
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations. This veneer cement is made from a complimentary hydrophilic resin and filler system, which creates compatibility between the tooth surface and restorative materials. AURAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding agents when bonding to dentin is not required. Equally, the surface of the restoration should also be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents are not required for the use of this product.
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
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Indicated Patient Age Range
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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)
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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.
RelyX Veneer Cement, ESPE/3M, Variolink Veneer Cement, Ivoclar, Calibra, Dentsply, Nexus, Kerr
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
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
510 (k) Premarket Notification AURAVeneer Cement
| enali corporation | K073101 | 510 (k) Premarket Notification | |
|---|---|---|---|
| AURAVeneer Cement | |||
| SUMMARY OF SAFETY AND EFFECTIVENESS DATA | |||
| Dr. Jan G. Stannard | |||
| 134 Old Washington Street | |||
| Hanover, MA 02339-1629 | Telephone | ||
| Fax | |||
| j_stannard@comcast.net | 781-826-9190 | ||
| 781-826-9190 | |||
| DEVICE | |||
| Trade Name: AURAVeneer Cement | |||
| Classification Name: Cement, Dental | |||
| FDA Product Code: 872.3275 | JAN 17 2008 | ||
| PREDICATE DEVICES: | |||
| RelyX Veneer Cement, ESPE/3M | |||
| Variolink Veneer Cement, Ivoclar | |||
| Calibra, Dentsply | |||
| Nexus, Kerr | |||
| DESCRIPTION AND INTENDED USE: | |||
| AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and | |||
| composite restorations. This veneer cement is made from a complimentary hydrophilic resin and | |||
| filler system, which creates compatibility between the tooth surface and restorative materials. AU- | |||
| RAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place | |||
| without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided | |||
| in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are | |||
| also available. It is recommended that enamel surfaces, which are uncut, be etched or micro- | |||
| abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding | |||
| agents when bonding to dentin is not required. Equally, the surface of the restoration should also | |||
| be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents | |||
| are not required for the use of this product. | |||
| COMPARISON WITH PREDICATE PRODUCTS: | |||
| AURAVeneer Cement is substantially equivalent in design, composition and intended use to the | |||
| products listed above. Please see page 12 for the entire comparison. | |||
| SAFETY AND EFFECTIVENESS: | |||
| AURAVeneer Cement is substantially equivalent in design, composition, performance, intended | |||
| use and effectiveness to the predicate kit products listed above. | |||
| The predicate products have been found substantially equivalent under the 510(k) premarket | |||
| notification process as Class II Dental Devices under CFR EBC 872.3765, LBH 872.3260, and | |||
| EBF 872.3690. | |||
| According to the NIH Technology Assessment conference on Effects and Side-Effects of Dental | |||
| Restorative Materials: "General usage of these materials over about 30 years indicates a high | |||
| benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no | |||
| evidence of short-term or long-term risk...There is no suspicion of any problems after virtually bil- | |||
| lions of procedures in the United States. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
JAN 17 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jan G. Stannard President DENALI Corporation 134 Old Washington Street Hanover, Massachusetts 02339
Re: K073101
Trade/Device Name: AURAVeneer Cement Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 21, 2007 Received: January 3, 2007
Dear Dr. Stannard:
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.
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Page 2 - Dr. Stannard
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Sude y Richmond.
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
3
enali corporation
INDICATIONS FOR USE STATEMENT
510 (k) Premarket Notification
AURAVeneer Cement
510 (k) Number
(if known)
Device Name
AURAVeneer Cement
Indications for Use:
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and
composite restorations.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kunne
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use
8