Nobel Biocare's Procera® AllCeram Fusing Material is a glass based powder which is mixed with distilled water. It is intended to be used to fuse together the sections of an aluminum oxide dental bridge.

Device Description

The Nobel Biocare Procera® All Ceram Fusing Material is a glass powder, which is combined with distilled water to produce a mixture of "pasty" consistency. The Procera fusing material is used to fuse together the sections of a dental bridge. The dental bridge sections consists of densely sintered, high purity aluminum oxide copings and a pontic. Procera® AllCeram Porcelain is then applied to the surface of the dental bridge structure.

AI/ML Overview

This document is a 510(k) summary for a dental fusing material, focusing on its substantial equivalence to predicate devices rather than clinical performance studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here is an analysis based on the given input:

1. A table of acceptance criteria and the reported device performance

Based on the provided document, specific "acceptance criteria" and "reported device performance" in the context of a clinical study are not explicitly stated or detailed. The submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The closest interpretation of "acceptance criteria" here is the regulatory bar for substantial equivalence, which is whether the device has "essentially identical compositions" and "same intended use" as predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantially equivalent to predicate products in:	The Nobel Biocare Procera AllCeram Fusing Material is substantially equivalent to Vita In-Ceram (K#913644) and Gdc 3338, Dental Solder Alloy (K#920887).
- Composition	The Procera AllCeram Fusing Material has "essentially identical compositions" to In-Ceram.
- Intended Use	Both Procera AllCeram Fusing Material and Gdc 3338, Dental Solder Alloy are used to "fuse" sections/components of a dental bridge, thus having the "same intended use."
- Technological Characteristics	The technological characteristics between the Procera® AllCeram Fusing Material and the predicate products are "equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission is a Pre-market Notification (510(k)) and primarily relies on a comparison to predicate devices, not on a clinical study with a "test set" in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As no clinical study or "test set" is detailed, the establishment of ground truth by experts is not applicable to this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. As no "test set" or clinical study with adjudicated results is described, an adjudication method is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device is a "glass powder" for fusing dental bridge sections, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided. The device is a physical material, not an algorithm. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. As there's no clinical trial or "test set" data presented, there's no ground truth data from such a study. The "ground truth" for this submission is implicitly the established properties and performance of the predicate devices for comparison.

8. The sample size for the training set

This information is not provided. The device is a physical material, not an AI or machine learning model. Therefore, a "training set" in the context of an algorithm is not applicable.

9. How the ground truth for the training set was established

This information is not provided. As there is no training set for an algorithm, the ground truth establishment for such a set is not applicable.

Summary

{0}------------------------------------------------

Pre-market Notification Page -3-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Ka983453

510(k) Summary of Safety and Effectiveness VII.

A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.

B. Name of the Device

The device is a glass powder used to fuse the sections of a dental bridge together. The dental bridge sections consists of densely sintered, high purity aluminum oxide copings and a pontic, which Porcelain All Ceram is applied to the surface.

C. The Predicate Product

The predicate products used in this Pre-market Notification are Vita In-Ceram (K#913644) Manufactured by Vident and Gdc-3338, Dental Solder Alloy (K#920887) manufactured by J.M. Ney.

D. Description of Device

{1}------------------------------------------------

E. Intended Use of the Device

F. Comparison of Technological Characteristics

The technological characteristics between the components of the Procera® AllCeram Fusing Material and the corresponding predicate products, Vita InCeram by Vident and Gdc 3338 Dental Solder Alloy by J.M. Ney are equivalent.

VIII. Substantial Equivalence

The Nobel Biocare Procera AllCeram Fusing Material, is a glass based powder, which is mixed with distilled water to create a fusing material for the sections of an aluminum oxide dental bridge. The aluminum oxide bridge is comprised of two copings and a pontic. To create the dental bridge using the Procera fusing material, the dental laboratory technician makes a refractory model from the patient's dental impression. The copings are placed on the refractory model with the pontic positioned between. Next the Procera fusing material is mixed with the appropriate amount of distilled water to form a "pasty" mixture, which is then applied to the occlusal surfaces of the dental bridge joints and allowed to air dry. One must sandblast the unfinished dental bridge at this point to remove any excess fusing material. Next Procera AllCeram Porcelain is applied to all surfaces of the bridge structure and then it is placed into a heated porcelain firing furnace.

Nobel Biocare's Procera AllCeram Fusing Material is substantially equivalent to the commercially available In-Ceram (K#913644) in that these products have essentially identical compositions and they are both used in the construction of dental bridges. The Procera AllCeram Fusing Material is also believed to be substantially equivalent to the Gdc 3338, Dental Solder Alloy (K#920887) in that both devices are used to "fuse" the various sections/components of a dental bridge, thus having the same intended use. Nobel Biocare's Procera AllCeram Fusing Material will be supplied in 5 gram, 10 gram, 20 gram and 40 gram quantities.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

Ms. Betsy A. Brown Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 Westmont, Illinois 60559

Re : K983453 Trade Name: Procera® All Ceram Fusing Material Regulatory Class: II Product Code: EIH September 23, 1998 Dated: September 30, 1998 Received:

Dear Ms. Brown:

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 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Ms. Brown

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberry of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markeess production over 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 regulation entitled, "Misbranding by reference to 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.fdaygov/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

{4}------------------------------------------------

510(k) Number (if known):	K983453
---------------------------	---------

Procera® AllCeram Fusing Material Device Name:

Indications For Use:

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices ીલુદ્ રાપ 510(k) Number

Prescription Use ﺴﻠ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.