(180 days)
No
The summary describes a dental crown made from zirconia and the process of designing and fabricating it. There is no mention of AI or ML being used in the design, fabrication, or intended use of the device.
No
The device restores chewing function, which is a physiological process, but it does not treat or prevent a disease or condition, which is a characteristic of a therapeutic device.
No
Explanation: The device is a dental crown intended to restore chewing function and provide a natural tooth-like appearance. It is a prosthetic device, not one that diagnoses conditions.
No
The device description clearly states it is a physical dental restoration made from zirconia material, which is a hardware component. While software is used in the design process, the final device is a physical object.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NobelProcera HT ML FCZ Crown is a dental prosthesis designed to replace a natural tooth and restore chewing function. It is a physical device that is placed in the patient's mouth.
- Intended Use: The intended use is to restore chewing function and provide a natural tooth-like appearance. This is a restorative and functional purpose, not a diagnostic one.
- Device Description: The description clearly states it is an "individualized dental restoration" and a "replacement for a natural tooth."
- Anatomical Site: The anatomical site is the oral cavity/tooth, where the device is physically placed.
- No Biological Samples: There is no mention of the device being used to test biological samples from the patient.
The device is a medical device, specifically a dental prosthesis, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.
Product codes
ELL
Device Description
NobelProcera® HT ML FCZ (High Translucent Multi Lavered Full Contour Zirconia) Crown is an individualized dental restoration made from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Crown is intended to be a replacement for a natural tooth. After finalizing the NobelProcera® HT ML FCZ Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Crown is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using the NobelProcera® system (NobelDesign) or supported third party CAD systems. The crown, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratory, hospital or dental practice, clinician
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)
No clinical or non-clinical test data was used to support the substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6. 2016
Nobel Biocare Ab % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare Usa LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K153534
Trade/Device Name: Nobelprocera Ht Ml Full Contour Zirconia Crown Regulation Number: 21 CFR 872.3920 Regulation Name: Porcelain Tooth Regulatory Class: Class II Product Code: ELL Dated: December 8, 2015 Received: December 9, 2015
Dear Charlemagne Chua:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runne, DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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)
Device Name
NobelProcera HT ML Full Contour Zirconia Crown
Indications for Use (Describe)
NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
I. SUBMITTER
Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348
Submitted for: NobelBiocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date Prepared: June 1, 2016
II. DEVICE
Name of Device: NobelProcera HT ML Full Contour Zirconia Crown Common or Usual Name: Porcelain tooth Classification Name: Porcelain tooth (21 CFR 872.3920) Regulatory Class: II Product Code: ELL
III.PREDICATE DEVICE
Primary predicate: Nobel Biocare - Procera Copings and Pontic (K032562)
Reference predicate: Kuraray Noritake Dental Inc. - Katana Zirconia (K143439)
IV. DEVICE DESCRIPTION
NobelProcera® HT ML FCZ (High Translucent Multi Lavered Full Contour Zirconia) Crown is an individualized dental restoration made from translucent multi-layered zirconia material.
NobelProcera® HT ML FCZ Crown is intended to be a replacement for a natural tooth. After finalizing the NobelProcera® HT ML FCZ Crown in the dental laboratory, it is cemented or bonded onto a tooth or artificial abutment, by a
A.4.
4
clinician, to provide a natural tooth like appearance and to restore chewing functionality in the patient's mouth.
To achieve esthetics and required value and chroma of the surrounding natural teeth the NobelProcera® HT ML FCZ Crown is suitable for cut-back (veneering) or stain and glaze techniques.
The design of the NobelProcera® HT ML FCZ Crown is determined in a dental laboratory, hospital or dental practice by scanning, designing and ordering the crown using the NobelProcera® system (NobelDesign) or supported third party CAD systems. The crown, once ordered, is sent electronically to one of NobelProcera's centralized milling centers for fabrication.
V. INDICATIONS FOR USE
NobelProcera HT ML FCZ Crown is indicated for use as core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.
NobelProcera HT ML FCZ Crown is indicated for use as single crown that will be cemented to a natural or artificial tooth abutment.
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VI. Comparison of Technological Characteristics
| Characteristic | Candidate | Primary Predicate | Reference Predicate | |
|---|---|---|---|---|
| Features | NobelProcera Full Contour | |||
| Zirconia Crown | Procera Coping and Pontic (K032562) | Katana Zirconia | ||
| (K143439) | ||||
| Material | Zirconium Oxide (Katana Zirconia | |||
| K143439) | Zirconium Oxide | |||
| Aluminum Oxide | Zirconium Oxide | |||
| Shape | Full anatomic contour | Fixed thickness | N/A | |
| Design | ||||
| Method | CAD | CAD and Wax-up | N/A | |
| Manufacturing | ||||
| Method | Nobel Biocare in-house CAM | Nobel Biocare in-house CAM | N/A | |
| Intended | ||||
| Use/Principles of | ||||
| Operation | NobelProcera Full Contour | |||
| Zirconia Crowns are intended for | ||||
| use as an aid in prosthetic | ||||
| rehabilitation | Intended for use as core structures of a prosthetic device | |||
| for the oral cavity. | Katana Zirconia is used | |||
| for the fabrication of the | ||||
| all-ceramic restorations | ||||
| (frameworks, FCZ | ||||
| crowns, FCZ bridges, | ||||
| inlays, onlays and | ||||
| veneers.) | ||||
| Indications for Use | NobelProcera HT ML FCZ Crown | |||
| is indicated for use as core | ||||
| structure of an artificial prosthesis | ||||
| for partially edentulous patients in | ||||
| the need of prosthetic oral | ||||
| reconstruction in order to restore | ||||
| chewing function. | ||||
| NobelProcera HT ML FCZ Crown | ||||
| is indicated for use as single | ||||
| crown that will be cemented to a | ||||
| natural or artificial tooth abutment. | 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. | KATANA Zirconia is | |||
| used for the fabrication | ||||
| of the all-ceramic | ||||
| restorations | ||||
| (frameworks, FCZ | ||||
| crowns, FCZ bridges, | ||||
| inlays, onlays and | ||||
| veneers.) | ||||
| Thickness | 0.4mm (Anterior) | |||
| 0.7 mm (Pre-molar and Molar) | 0.4 mm and 0.6 mm | N/A |
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Analysis of Differences Between Subiect Device and Predicates
The predicate Nobel Biocare Procera Copings and Pontic contain both crown and pontic. When two copings are used in conjunction with a pontic a three-unit bridge may be made. In addition to the use as a three-unit bridge the copings of the predicate, when used independently, are indicated for use as a single crown. The subject device is only indicated for single crown use. The change in Indication for Use for the subject device to only a single crown does not affect the determination of substantial equivalence since single crown use is within the previously cleared predicate Indications for Use.
The NobelProcera HT ML Full Contour Zirconia Crown is made entirely of the Katana Zirconia predicate material (K143439) which is cleared for the fabrication of full contour crowns such as the subject device.
The primary difference between the NobelProcera HT ML Full Contour Zirconia Crown and the predicate Procera Coping and Pontic (K032562) is that the subject device is made in an anatomic full contour tooth shape or a cut-back. The full contour crown is produced with the intention to create the final tooth shape, made entirely from solid zirconia. The predicate NobelProcera Coping looks more like a "shell" that must be built up with dental ceramic so that the dental technician can create the final tooth shape.
Intended Use:
The difference between the subject device and predicate intended uses are related to the specific role within the process of making a crown that the device is intended to fulfill. In the case of the Procera Coping and Pontic (K032562) the coping is the core of a crown rather than the full crown shape of the subject device. The Katana Zirconia (K143439) intended use is that of a porcelain powder for clinical use (872.6660) used in the manufacture of the subject device.
Summary:
The changes detailed above do not raise different questions to support substantial equivalence determination.
VII. PERFORMANCE DATA
No clinical or non-clinical test data was used to support the substantial equivalence determination.
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VIII. CONCLUSIONS
The NobelProcera HT ML Full Contour Zirconia Crown was evaluated for substantial equivalence. Based on technological characteristics, the NobelProcera HT ML Full Contour Zirconia Crown has been shown to be substantially equivalent to the NobelProcera Coping and Pontic.