(180 days)
No
The summary describes a dental implant bridge made of zirconia and titanium. There is no mention of AI or ML in the intended use, device description, or performance studies. The "ML" in the device name likely refers to "Multi-Layered" zirconia, not Machine Learning.
No
The device is described as an anatomically shaped bridge and/or framework for restoring chewing function and is made of zirconia and titanium. This description indicates it is a prosthetic device for dental restoration, not a therapeutic device designed to treat a disease or medical condition.
No
This device is a dental implant bridge used for restoring chewing function in edentulous jaws, not for diagnosing medical conditions.
No
The device description clearly states it is a physical dental implant bridge made of titanium and zirconia materials, requiring laboratory processing and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore chewing function in partially or totally edentulous jaws by providing a dental bridge. This is a mechanical and structural function within the body.
- Device Description: The device is a physical implant-supported dental bridge made of titanium and zirconia. It is designed to be placed in the mouth.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The device is a medical device, specifically a dental prosthetic, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients.
The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14 units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades.
The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or totally edentulous jaws
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)
The fatigue limit of the NobelProcera HT ML FCZ Implant Bridge and Framework was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
Validation of the recommended sterilization parameters was conducted according to ISO 17665-1 and ISO 17665-2.
Cytotoxicity testing according to ISO 10993-5 as well as GC-MS analysis for leacables/extractable was conducted on the ISO 6872 ceramic and ASTM F136 titanium alloy material composition of the device.
No clinical data was used to support the decision of substantial equivalence.
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.
Nobel Biocare - NobelProcera Implant Bridge Zirconia (K091907)
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.
Nobel Biocare -Angulated Screw Channel Abutment Conical Connection (K132746)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2016
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K160158
Trade/Device Name: NobelProcera HT ML FCZ Implant Bridge and Framework Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 14, 2016 Received: June 15, 2016
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.
1
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 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,
Image /page/1/Picture/8 description: The image shows a signature with the name "Tina Kiang" written above the letter "S". The signature is written in black ink and is on a white background. The signature is stylized and difficult to read.
for 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K160158 | |
| Device Name | NobelProcera HT ML FCZ Implant Bridge and framework | |
| Indications for Use (Describe) | The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. | |
| 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) | | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | |
| Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | |
| FORM FDA 3881 (1/14)
JUNE 2016 | Page 1 of 1 | |
| | PSC Publishing Services (301) 443-6740 EF
K160158-S001
Page 25 of 412 | |
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3
A.4.
510(k) Summary
SUBMITTER .
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
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
Date Prepared: July 15, 2016
II. DEVICE
Name of Device: NobelProcera HT ML FCZ Implant Bridge and Framework Common or Usual Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3640) Requlatory Class: II Product Code: NHA
III. PREDICATE DEVICE
Nobel Biocare - NobelProcera Implant Bridge Zirconia (K091907) Nobel Biocare -Angulated Screw Channel Abutment Conical Connection (K132746)
IV. DEVICE DESCRIPTION
The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients.
The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14
Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016
4
units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades.
The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.
V. INDICATIONS FOR USE
The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technological
| characteristics | Subject Device | Predicate | |
|---|---|---|---|
| NobelProcera HT ML FCZ | |||
| Implant Bridge and Framework | NobelProcera Implant Bridge Zirconia | ||
| (K091907) | |||
| Design Features | Compatible | ||
| Implant | |||
| /Abutment | |||
| Platform | Nobel Biocare | ||
| Internal Conical Connection NP, RP, WP | |||
| Internal Tri-Channel NP, RP, WP, 6.0 | |||
| External Hex NP, RP, WP | |||
| Multi-unit NP/RP, WP | Nobel Biocare | ||
| Internal Conical Connection NP, RP, WP | |||
| Internal Tri-Channel NP, RP, WP, 6.0 | |||
| External Hex NP, RP, WP | |||
| Multi-unit NP/RP, WP | |||
| Astra Tech | |||
| Yellow, Aqua, Lilac | |||
| Straumann | |||
| Octagon 3.5, 4.8, 6.5 | |||
| Bone Level 3.3, 4.1/4.8 | |||
| Biomet 3i | |||
| Internal 3.4, 3.75/4.0, 5.0, 6.0 | |||
| External 3.4, 4.1, 5.0, 6.0 | |||
| Zimmer | |||
| Screw-Vent 3.5, 4.5, 5.7 | |||
| AdVent 4.5 | |||
| Device Material | Zirconium Oxide with titanium vanadium alloy implant | ||
| interface for Internal Conical Connection. | Zirconium Oxide | ||
| Bridge Design | Individualized full anatomic contour or framework | Individualized framework | |
| Arc Length | 2 to 14 units | 2 to 14 units | |
| Design method | CAD | Wax-up or CAD design |
Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016
6
| Technological
| characteristics | Subject Device | Predicate |
|---|---|---|
| Manufacturing | ||
| method | NobelProcera HT ML FCZ | |
| Implant Bridge and Framework | NobelProcera Implant Bridge Zirconia | |
| (K091907) | ||
| Industrialized manufacturing at NobelProcera | ||
| manufacturing facility | Industrialized manufacturing at NobelProcera | |
| manufacturing facility | ||
| Intended use | The NobelProcera HT ML FCZ Implant Bridge and | |
| Framework are customized dental implant bridges | ||
| intended to restore chewing functions. The Implant | ||
| Bridge is intended to directly attaches to the endosseous | ||
| dental implants and/or onto Nobel Biocare's Multi-unit | ||
| Abutments with clinical screws and provides a platform | ||
| for restoration. | The NobelProcera Implant Bridge Zirconia is a bridge | |
| framework that attaches to implants or abutments. The | ||
| NobelProcera Implant Bridge Zirconia is intended to be | ||
| finished into a dental prosthesis using standard laboratory | ||
| dental materials such as resin composite or porcelain | ||
| veneer. | ||
| Indication for Use | The NobelProcera® HT ML FCZ (full contour zirconia) | |
| and framework Implant Bridge are indicated for use as a | ||
| bridge anatomically shaped and/or framework in the | ||
| treatment of partially or totally edentulous jaws for the | ||
| purpose of restoring chewing function. | The NobelProcera Implant Bridge Zirconia is indicated for | |
| use as a bridge framework in the treatment of partially or | ||
| totally edentulous jaws for the purpose of restoring | ||
| chewing function. | ||
The difference in the Indications for Use is the addition of the term "bridge anatomically shaped" allows for an anatomically shaped bridge as compared to just a bridge framework in the primary predicate device. The addition of an anatomically shaped bridge does not change the intended use of the implant bridge dental abutment device.
The additional difference between the subject device and the primary predicate is the inclusion of a titonia material and the implant body. The reference predicate (K132746) supports the addition of a titanium interface between the zirconia material and the implant body.
Nobel Biocare Traditional 510(k) Notification NobelProcera HT ML FCZ Implant Bridge and Framework July 2016
7
VII. PERFORMANCE DATA
The fatique limit of the NobelProcera HT ML FCZ Implant Bridge and Framework was determined using a modified version of ISO 14801. The modifications to ISO 14801 were done to reflect the likely worst-case clinical use of the device. Both the subject and predicate device were tested under identical conditions. The results of the testing were used to address questions related to substantial equivalence based on difference in design between the subject and predicate devices.
Validation of the recommended sterilization parameters was conducted according to ISO 17665-1 and ISO 17665-2.
Cytotoxicity testing according to ISO 10993-5 as well as BC-MS analysis for leacables/extractable was conducted on the ISO 6872 ceramic and ASTM F136 titanium alloy material composition of the device.
No clinical data was used to support the decision of substantial equivalence.
VIII. CONCLUSIONS
The NobelProcera HT ML FCZ Implant Bridge and Framework was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data included in this submission, the NobelProcera HT ML FCZ Implant Bridge and Framework has been shown to be substantially equivalent to the NobelProcera Implant Bridge Zirconia.