(170 days)
Nobel Biocare's Procera Copings and Pontic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.
The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.
Nobel Biocare's Procera® Copings and Pontic are prefabricated devices intended for use as core structures of prosthetic devices, such as three-unit bridges. The Copings are also intended for use as the core structure of single crowns.
Nobel Biocare's Procera* Copings are used with the Pontic in a three-unit bridge. The Coping serves as the core structure of the two side crowns, while the Pontic serves as the core structure of the center unit in the three-unit bridge.
Nobel Biocare's Procera" Copings are also the core structure of a single crown that can be placed on both a natural or artificial tooth abutment.
Nobel Biocare's Procera* Copings and Pontic are manufactured from either Aluminum Oxide powder or Zirconium Oxide powder. The ceramic materials (both Aluminum Oxide and Zirconium Oxide) enhance the esthetics of the restoration by giving the teeth a natural appearance.
This document describes a 510(k) premarket notification for the Nobel Biocare Procera Copings and Pontic. It does not contain information about a study that assesses acceptance criteria in the context of device performance metrics typically found in AI/ML medical device submissions.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them with information like sample sizes, ground truth establishment, or expert qualifications. This document focuses on the regulatory clearance process for a dental prosthetic device based on substantial equivalence to predicate devices, not on a performance study comparing the device to specific acceptance criteria.
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Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically 'K032562'. The characters are handwritten and appear to be part of a code or identification number. The writing style is simple and clear, making the characters easily distinguishable.
FEB = 6 2004
510(k) Summary of Safety and Effectiveness 1.5
| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|---|---|
| Address: | Nobel Biocare USA Inc.22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 7830 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | August 19, 2003 |
| Classification Name: | Porcelain Tooth (21 CFR 872.3920) |
| Trade or Proprietaryor Model Name: | Procera ® Copings and Pontic |
| Legally Marketed Device(s): | CeraOne Abutment System (K910611)Aluminum Oxide Powder (K001418)Y-TZP Powder and Procera ® AllZirkon (K010630) |
Device Description:
Nobel Biocare's Procera® Copings and Pontic are prefabricated devices intended for use as core structures of prosthetic devices, such as three-unit bridges. The Copings are also intended for use as the core structure of single crowns.
Nobel Biocare's Procera* Copings are used with the Pontic in a three-unit bridge. The Coping serves as the core structure of the two side crowns, while the Pontic serves as the core structure of the center unit in the three-unit bridge.
Nobel Biocare's Procera" Copings are also the core structure of a single crown that can be placed on both a natural or artificial tooth abutment.
Nobel Biocare's Procera* Copings and Pontic are manufactured from either Aluminum Oxide powder or Zirconium Oxide powder. The ceramic materials (both Aluminum Oxide and Zirconium Oxide) enhance the esthetics of the restoration by giving the teeth a natural appearance.
Indications for Use:
Nobel Biocare's Procera" Copings and Pontic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.
The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 6 2004
Nobel Biocare AB C/O Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway, Yorba Linda, California 92887
Re: K032562
Trade/Device Name: Procera Copings and Pontic Regulation Number: 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: II Product Code: ELL Dated: November 14, 2003 Received: November 17, 2003
Dear Ms. Mason:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Mason
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
Clarks
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K032562
Device Name: Procera Copings and Pontic
Indications For Use:
Nobel Biocare's Procera Copings and Pontic are indicated for use as core structures of an artificial prosthesis, i.e. a three-unit bridge, for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
The Pontic is indicated as the core structure of the center unit and the Copings are indicated as the core structures of the two side crowns, thereby forming the three-unit bridge.
The Copings are also indicated for use as single crowns that will be cemented to a natural or artificial tooth abutment in the treatment of partially edentulous patients in order to restore chewing function.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runny
(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental I
Page 1 of 1
510(k) Number: K032562
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.