(70 days)
RelyX Cement, Variolink Cement, Calibra Cement, Nexus Cement
Not Found
No
The 510(k) summary describes a dental cement and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a self-adhesive cement used for bonding dental restorations, which is a restorative function, not a therapeutic one. It's used to bond existing ceramic and composite materials.
No
Explanation: The device is described as a self-adhesive cement for bonding restorations, and its intended use is for bonding ceramic and composite restorations, which are therapeutic/restorative functions, not diagnostic.
No
The device description clearly states it is a "self-adhesive cement," which is a physical material, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "bonding of ceramic and composite restorations." This describes a material used in a dental procedure to physically attach restorations to teeth.
- Device Description: The description reinforces that it is a "self-adhesive cement recommended for the bonding of ceramic and composite restorations." This further clarifies its function as a bonding agent.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or kits for testing.
The device is a dental cement, which is a material used in a clinical procedure, not a diagnostic test performed in vitro (outside the body).
N/A
Intended Use / Indications for Use
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
Product codes
EMA
Device Description
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
RelyX Cement, ESPE/3M, Variolink Cement, Ivoclar, Calibra Cement, Dentsply, Nexus Cement, Kerr
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K08 3398
SUMMARY OF SAFETY AND E-FFECTIVENESS DATA
Dr Jan G Stannard 134 Old Washington Street Hanover, MA 02339-1629
DEVICE
Trade Name CERCOM Cement Classification Name Cement, Dental FDA Product Code 872 3275
781-826-9190 Telephone Fax 781-826-9190 | stannard@comcast net
JAN 2 6 2009
PREDICATE DEVICES RelyX Cement, ESPE/3M Variolink Cement, Ivoclar Calibra Cement, Dentsply Nexus Cement, Kerr
DESCRIPTION AND INTENDED USE
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
COMPARISON WITH PREDICATE PRODUCTS
CERCOM Cement is substantially equivalent in design, composition and intended use to the products listed above
SAFETY AND EFFECTIVENESS
CERCOM Cement is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement 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 EMA 872 3275
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr Jan G Stannard President Denalı R&D Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629
JAN 2 6 2009
Re K083398 Trade/Device Name CERCOM Cement Regulation Number 21 CFR 872 3275 Regulation Name Dental Cement Regulatory Class II Product Code EMA Dated November 12, 2008 Received November 17, 2008
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 affectung 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 - 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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 (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sincerely yours,
Anthony D. Austin for
Ginette Y Michaud, M D
Acting 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 UST: STATEMENT
510 (k) Number _______________________________________________________________________________________________________________________________________________________________ (if known)
Device Name
CERCOM Cement
4683398
Indications for Use:
CERCOM Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations
Please do not write below this line Conlinue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K08 3398 |
|---|---|
| ---------------- | ---------- |
| Prescription Use
| (Per 21 CFR 801 109) | or | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |