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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a dental device (CERANA) and not a study report. Therefore, it does not contain the acceptance criteria or a study proving the device meets those criteria in the format requested.

510(k) summaries primarily establish substantial equivalence to a predicate device, focusing on technological characteristics and intended use, rather than presenting detailed performance study results with specific acceptance criteria.

The sections you requested (acceptance criteria table, sample sizes, expert qualifications, etc.) are typically found in clinical study reports or summaries of performance testing, which are not present in this 510(k) submission.

Explanation of document content regarding performance:

Technological Characteristics: The document states that CERANA "has been tested to show comparison with the IPS Empress predicate device material." This implies some form of testing was done to demonstrate similarity/equivalence, but no specific performance metrics, acceptance criteria, or study details are provided.
Substantial Equivalence: The FDA's letter (on pages 2-3) confirms the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the applicant, which includes demonstrating similar technological characteristics and intended use.
No detailed study information: The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details of ground truth establishment.
- Information on expert panels, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set details, as this is a physical dental material, not an AI/software device.

Summary

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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 ABBox 1082S-262 21 ÄngelholmSweden
	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:

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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.

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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

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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

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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:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)
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Prescription Use Per 21 CFR 801.109

Over-the-Counter

Susan Rumm

(Division Sign-Off Division of Dental, Infection Control, and General Hospital Device ાલું લ 510(k) Number

Regulation Number and Section

§ 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.