(49 days)
K#913644, K#920887
Not Found
No
The summary describes a material used for fusing dental bridges and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is a material used to fuse sections of a dental bridge together, not to treat a disease, injury, or alleviate a condition directly in a patient. It is used by a dental laboratory technician to construct the dental bridge, which subsequently is used in a patient, but the fusing material itself is not a therapeutic device.
No
Explanation: The device description states its purpose is to "fuse together the sections of an aluminum oxide dental bridge," indicating a constructive or manufacturing role rather than a diagnostic one. There is no mention of identifying or analyzing conditions.
No
The device is a physical material (glass powder) used to fuse dental bridge sections, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fuse together sections of a dental bridge, which is a dental restoration used in the mouth. This is a mechanical/structural function, not a diagnostic one.
- Device Description: The description details a material used for bonding dental components. It doesn't mention any interaction with biological samples (like blood, urine, tissue) for the purpose of diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in the creation of a dental prosthesis, which is then placed in vivo (in the body), but the device itself is not performing a diagnostic function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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): 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.
K#913644, K#920887
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.
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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
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.
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E. Intended Use of the Device
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.
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.
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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.
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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
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| 510(k) Number (if known): | K983453 |
|---|---|
| --------------------------- | --------- |
Procera® AllCeram Fusing Material Device Name:
Indications For Use:
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.
(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)