DENZIR by DENTRONIC AB | FDA 510(k) Summary

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Device Description

Denzir™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials.Denzir™ inlays are alternatives to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

AI/ML Overview

This document is a 510(k) summary for Denzir™, a dental restorative material, and does not contain the specific details about acceptance criteria and a study proving device performance as typically expected for software or AI-driven medical devices. The information provided focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and meeting general material standards.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

However, I can extract the relevant information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Criterion	Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets US and European accepted methods	Product tested and meets these methods.
Material Standard	ISO 6872 (1995)	Product meets ISO 6872 (1995).
Luting Materials	Meet valid ISO standards for various product types	Luting materials prescribed for use with Denzir™ meet currently valid ISO standards.

Missing Information (Not available in the provided text):

Sample size used for the test set and data provenance.
Number of experts used to establish ground truth for the test set and their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
Information on a standalone (i.e., algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
Sample size for the training set.
How ground truth for the training set was established.

General Observations from the Text:

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, a common pathway for medical device clearance. This usually involves showing similar intended use, technological characteristics, and safety/effectiveness profiles.
The material is certified for biocompatibility and meets ISO standards, which indicates it has undergone testing appropriate for a dental material.
The device is a physical dental material (zirconium dioxide-yttrium oxide ceramic) for inlays, onlays, veneers, crowns, and bridges, not a software or AI-driven diagnostic/treatment planning device. Therefore, the types of studies and acceptance criteria typically associated with AI devices (e.g., sensitivity, specificity, MRMC studies) are not applicable or expected in this submission.

Summary

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SEP 2 9 1999

K984201

XI. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. October 8, 1998. [Separate Pages]

A. Anders Sundh, Dentronic, Box 733, S-931 27 Skelleftea, Sweden. Phone 46 910 835 70.

I. Classification Names and numbers: Material, tooth shade resin, 76EBF, Class II.

Porcelain powder for clinical use, 76EIH, Class II.

II. Common/Usual Name: Dental restorative material, porcelain powder/blocks
III. Proprietary Names: Denzir™

IV. Establishment Registration Number: Foreign, in process

V. Classification: These are Class II devices, intended to restore carious lesions or structural defects in teeth, described in CFR 872.3690. Like porcelain powder, this device is delivered in final form for use by the dentist, and is ceramic in nature. Porcelain powder is described in CFR 872.6660.

VI. Device Description: Denzir™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials.Denzir™ inlays are alternatives to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

VII. Substantial Equivalence: The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, to restore carious lesions or structural defects in teeth and are used as inlays, and onlays,
The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use. The technological features, although distinct, have the same intended use as the devices listed as equivalent.
Descriptive information provided shows that the materials from which Denzir™ are made are well established as the basis of many different kinds of implants, mainly more demanding than is the mouth. Denzir™ is equivalent in use and properties to devices described in K-973221, K-971869, and K-943168.

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This product has been tested for biocompatibility by methods accepted in the US. and Europe. The material meets ISO 6872 (1995) and has been CE marked for indicated uses. The luting materials prescribed for use with this materal meet currently valid ISO standards for the various product types.

(End of Summary)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 1999

Mr. Anders Sundh President Dentronic AB Box 733 S-931 27 Skellefteá Sweden

K984201 Re : Denzir™ Trade Name: Regulatory Class: II Product Code: EIH April 26, 1999 Dated: August 16, 1999 Received:

Dear Mr. Sundh:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 through 542 of

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Page 2 - Mr. Sundh

the Act for devices under the Electronic Product 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VIII.1 Indications for Use: [Separate Page]

510(k) Number: NA

Device Name: Denzir™

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation(ODB)

Prescription Use
(Per 21 CFR 801.109

uaa

Over-The-Counter Use_ (Optional Format 1-2-96)

(Division Sign5Off) Division of Dental, Infection Control, and General Hospital 510(k) Number Jumber L

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.