(89 days)
Not Found
No
The description focuses on the material properties and physical characteristics of the ceramic inlay, with no mention of AI or ML.
Yes
CERANA is an all-ceramic inlay used for dental restorations, which falls under the definition of a therapeutic device as it is intended to treat a condition (caries/missing tooth structure).
No
The device, CERANA, is described as an all-ceramic inlay used for dental restorations (filling, repairing crowns, etc.), which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that CERANA is an "all-ceramic inlay," which is a physical, hardware component used in dental restorations.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of CERANA is for the restoration of teeth (filling cavities, replacing fillings, repairing crowns and inlays). This is a therapeutic or restorative use, not a diagnostic one.
- Device Description: The description details a physical ceramic inlay designed to be placed in a patient's mouth. It doesn't describe a test or assay performed on biological samples outside the body.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for direct use in a patient's body to restore dental structure.
N/A
Intended Use / Indications for Use
CERANA is designed to be used in class I primary and secondary caries/replacement of filling, class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
CERANA is an all-ceramic inlay that has the same translucency as enamel, can be finished and polished just like enamel and has the same natural color as enamel. The inlays are pre-etched, silanised and ready to use, when removed from the hygienic blister package.
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)
CERANA, a prefabricated leucite-reinforced glass ceramic inlay, has been tested to show comparison with the IPS Empress predicate device material. In design and installation techniques it is similar to the Sonicsys inlay and Beta Quartz glass-ceramic insert predicate devices. In summary, no new technology, materials, or change in efficacy have been introduced in the manufacture of CERANA.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
1992
SEP 22 1999
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92
| Submitted by: | Nordiska Dental AB
Box 1082
S-262 21 Ängelholm
Sweden |
|-------------------|----------------------------------------------------------------|
| | Product Manager: Charlotte Asserup |
| | Fax Number: (+46) 461 44 33 99 |
| Date Prepared: | June 1, 1999 |
| Device Name: | |
| Proprietary Name: | CERANA |
| Common Name: | Ceramic dental filling |
Identification of Predicate Devices
Classification:
-
Ivoclar North America, Inc. IPS Empress, Ivoclar North America, Inc., 175 ● Pineview Dr., Amherst, NY 14228; 510(k) number K913372.
Class II, EIH -
Ivoclar North America, Inc. SONICSYS Inlay, Ivoclar North America, Inc., 175 ● Pineview Dr., Amherst, NY 14228; 510(k) number K972648.
-
Lee Pharmaceuticals. Precise ® Beta Quartz Glass-Ceramic Insert, Lee . Pharmaceuticals, 1444 Santa Anita Avenue, P.O. Box 3836, South El Monte, CA 91733; 510 (k) number K912256
Device Description:
CERANA is an all-ceramic inlay that has the same translucency as enamel, can be finished and polished just like enamel and has the same natural color as enamel. The inlays are pre-etched, silanised and ready to use, when removed from the hygienic blister package.
1
Indication for Use:
CERANA is designed to be used in class I primary and secondary caries/replacement of filling; class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays, and class IV restorations.
Technological Characteristics
CERANA, a prefabricated leucite-reinforced glass ceramic inlay, has been tested to show comparison with the IPS Empress predicate device material. In design and installation techniques it is similar to the Sonicsys inlay and Beta Quartz glass-ceramic insert predicate devices. In summary, no new technology, materials, or change in efficacy have been introduced in the manufacture of CERANA.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a bird or abstract human figure with three curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 22 1999
Nordiska Dental AB C/O Ms. Christine Emanuel Regulatory Affairs Consultant, TECSA TECSA Technical Services 1205 De La Vina Santa Barbara, Califirnia 93101
K992161 Re : Trade Name: CERANA Regulatory Class: II Product Code: EIH June 21, 1999 Dated: Received: June 25, 1999
Dear Ms. Emanuel:
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 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). 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 (Premarket Approval), 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 895. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Ms. Emanuel
through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Runner
imothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement. *For a new submission, do NOT fill in the 510(k) number blank
INDICATIONS FOR USE
Applicant:. Nordiska Dental AB
510(k) Number (if known): N/A*
Device Name: CERANA
Indications For Use:
CERANA is designed to be used in class I primary and secondary caries/replacement of filling, class II primary and secondary caries and replacement of filling; restoration of ceramic crowns and repair of ceramic inlays; and class IV restorations.
(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
Susan Rumm
(Division Sign-Off Division of Dental, Infection Control, and General Hospital Device ાલું લ 510(k) Number