(98 days)
No
The summary does not mention AI, ML, or any related technologies in the device description or performance studies. The design process is described as using standard dental CAD/CAM software.
No
The device restores chewing function in edentulous jaws, which is a restoration of a physiological function, not treatment or prevention of a disease or condition.
No
The device is a restorative dental implant bridge designed to restore chewing function in edentulous patients, not to diagnose a condition.
No
The device is a physical dental implant bridge made of zirconia, designed and manufactured using CAD/CAM software but is not solely software.
Based on the provided information, the NobelProcera® Zirconia Implant Bridge is not an In Vitro Diagnostic (IVD) device.
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 patient-specific, screw-retained dental implant bridge made of zirconia. It is designed and manufactured to be physically placed in the mouth and connected to dental implants.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. Its purpose is purely restorative.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The NobelProcera Zirconia Implant Bridge does not fit this description.
N/A
Intended Use / Indications for Use
The NobelProcera® Zirconia 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
NHA
Device Description
NobelProcera Zirconia Implant Bridges (Dental Bridges) are patient-specific, dental implant supported, screw-retained dental implant bridges which are connected to compatible Nobel Biocare root-form endosseous dental implants or Multi-unit abutments and are intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing.
NobelProcera Zirconia Implant Bridges are made from 'Nacera Pean' (yttriastabilized tetragonal zirconia), Reference Device #1, K143071. The Dental Bridges are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo-approved dental scanner.
The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing.
NobelProcera Zirconia Implant Bridges are available for use with Nobel Biocare's root-form endosseous dental implants (Dental Implants) havinq Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment Connections (for MUA and MUA Plus). One Dental Bridge can feature connections to 2 to 10 Dental Implants.
All NobelProcera Zirconia Implant Bridges are provided with the required clinical and/or Prosthetic Screw: The clinical screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connect the Dental Bridge with a Multi-unit Abutment.
Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the external hex, internal tri-channel, or Multi-unit abutment connections.
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
dental laboratory, hospital or dental practice
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)
Fatigue Performance: Fatigue testing using a modified version of ISO 14801 (in saline solution) to reflect the clinical loading on bridges. Fatigue performance test was performed following the worst-case assessment. The Dental Bridge was manufactured from the Reference Device #1 Nacera Pearl (K143071), using the new connection with a MUA Plus as well as the Prosthetic Screw. Both the Subject and Predicate Devices 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.
Biocompatibility: A biocompatibility evaluation was conducted according to ISO 10993 – 1. The results demonstrated that biocompatibility testing consisting of cytotoxicity and chemical characterization using GC-MS analysis is appropriate to assess the biological safety of the subject device. Test samples are representative of the finish subject device as they are made from the same material, manufacturing environments, and specifications as the subject device. The results demonstrate the biocompatibility of the subject device.
Sterilization Validation: Validation for the cleaning and sterilization of the dental bridge and for the prosthetic screw was conducted. Sterilization validation was conducted per ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
No clinical data was used to support the decision of Substantial Equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K143071, K091907, K161598, K171799
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 3, 2020
Nobel Biocare AB Bernice Jim Regulatory Affairs Manager Vastra Hamngatan 1 Goteborg Gotlands Lan, 411 17 SWEDEN
Re: K202452
Trade/Device Name: NobelProcera Zirconia Implant Bridge Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 3, 2020 Received: November 4, 2020
Dear Bernice Jim:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
NobelProcera Zirconia Implant Bridge
Indications for Use (Describe)
The NobelProcera® Zirconia 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) |
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3
Image /page/3/Picture/0 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the text "Nobel Biocare" in black font. The letters are capitalized, and there is a trademark symbol after the word Biocare.
510(k) Summary – K202452
005-01 Submitter Information
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Contact Person: Bernice Jim, Ph.D. E-Mail: bernice.jim@nobelbiocare.com Phone: +41 79 855 00 73 Fax: +41 43 211 42 42
December 3, 2020
005-02 Device
| Proprietary name: | NobelProcera Zirconia Implant Bridge |
|---|---|
| Manufacturer: | Nobel Biocare Services AG |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
005-03 Predicate Device
| Predicate Device | |
|---|---|
| Proprietary Name: | NobelProcera HT ML FCZ Implant Bridge and Framework |
| (K160158) | |
| Manufacturer: | Nobel Biocare Services AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
4
| Proprietary Name: | Nacera Pearl (K143071) |
|---|---|
| Manufacturer: | DOCERAM Medical Ceramics GmbH |
| Common Name: | Porcelain Powder Blanks |
| Classification Name: | Porcelain Powder for Clinical Use |
| Regulation Number: | 21 CFR 872.6660 |
| Regulatory Class: | II |
| Product Code: | EIH |
Reference Device #2
| Proprietary Name: | NobelProcera Implant Bridge Zirconia (K091907) |
|---|---|
| Manufacturer: | Nobel Biocare Services AG |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
Reference Device #3
| Proprietary Name: | NobelZygoma 0° (K161598) |
|---|---|
| Manufacturer: | Nobel Biocare Services AG |
| Common Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3640 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA |
Reference Device #4
| Proprietary Name: | Elos Accurate® Customized Abutment (K171799) |
|---|---|
| Manufacturer: | Elos Medtech Pinol A/S |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
005-04 Device Description
NobelProcera Zirconia Implant Bridges (Dental Bridges) are patient-specific, dental implant supported, screw-retained dental implant bridges which are connected to compatible Nobel Biocare root-form endosseous dental implants or Multi-unit abutments and are intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing.
5
NobelProcera Zirconia Implant Bridges are made from 'Nacera Pean' (yttriastabilized tetragonal zirconia), Reference Device #1, K143071. The Dental Bridges are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo-approved dental scanner.
The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing.
NobelProcera Zirconia Implant Bridges are available for use with Nobel Biocare's root-form endosseous dental implants (Dental Implants) havinq Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment Connections (for MUA and MUA Plus). One Dental Bridge can feature connections to 2 to 10 Dental Implants.
All NobelProcera Zirconia Implant Bridges are provided with the required clinical and/or Prosthetic Screw: The clinical screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connect the Dental Bridge with a Multi-unit Abutment.
Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the external hex, internal tri-channel, or Multi-unit abutment connections.
Principle of Operation / Mechanism of Action
The NobelProcera Zirconia Implant Bridges (Dental Bridges) are used for dental restoration purposes. The Dental Bridge can mechanically be connected to endosseous dental implants directly with clinical screws (Implant Level) or it can be connected via Multi-unit Abutments (MUA Level) with Prosthetic Screws to restore chewing function.
Device/Accessory List
The NobelProcera Zirconia Implant Bridge is provided with the required clinical and/or prosthetic screws. Bridges intended to be connected to an implant with Internal Conical Connection are shipped with the Clinical Metal Adapter.
The NobelProcera Zirconia Implant Bridge is intended to be used with the following previously cleared or exempt accessories/devices from Nobel Biocare. The Subject device component 'Prosthetics Screws' are included in the Table 005-1 as well for the purpose of comprehensiveness.
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Table 005-1: NobelProcera Zirconia Implant Bridge compatibilities overview
| Compatible Implant /Abutment
Platform | Platform | Clinical Metal Adapter
(Article number) | Clinical Screw
(Article number) | Prosthetic Screws
(Article number) |
|--------------------------------------------------|--------------------------------------------------|--------------------------------------------|------------------------------------|---------------------------------------|
| Compatible Abutment Platform Sizes | | | | |
| Multi-unit
Multi-unit Plus | NP/RP/WP
except
Multi-unit External Hex WP | N/A | N/A | 301203
(Subject Device) |
| Multi-unit
Multi-unit Plus | External Hex WP | N/A | N/A | 301200
(Subject Device) |
| Compatible Implant Connection and Platform Sizes | | | | |
| Conical connection | NP | 38483
(K160158) | 37367
(K132746) | N/A |
| | RP | 38484
(K160158) | 37606
(K132746) | N/A |
| | WP | 38525
(K160158) | 37606
(K132746) | N/A |
| Tri-channel connection | NP | N/A | 28837
(K091904) | N/A |
| | RP | N/A | N/A | N/A |
| | WP | N/A | 28816
(K091904) | N/A |
| | 6.0 | N/A | N/A | N/A |
| External Hex | NP | N/A | 31171
(K905434) | N/A |
| | RP | N/A | 28815
(K091904) | N/A |
| | WP | N/A | 28844
(K091904) | N/A |
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005-05 Indications for use
The NobelProcera® Zirconia 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.
005-06 Substantial Equivalence Discussion
The Subject Device 'NobelProcera Zirconia Implant Bridge' from Nobel Biocare functions in a manner similar to and is intended for the same indications for use as the Predicate Device 'NobelProcera HT ML FCZ Implant Bridge and Framework' (K160158) marketed by Nobel Biocare. There are numerous identical design and technological characteristics such as indications for use, compatible dental implants connections, device material, bridge design (restoration type), bridge design with arc length and angulated screw channel, angulated screw channel angulation between 0° to 25°, and manufacturing method.
However, there are different technological characteristics: The Subject Device 'NobelProcera Zirconia Implant Bridge' is manufactured from a pre-sintered milling disk 'Nacera Pearl' (Reference Device #1, K143071) which allows for a maximum number of 10 implants as opposed to the Predicate which allows for 14 implants. The Dental Bridge extends the MUA level to allow connection with the Multi-unit Abutment Plus (MUA Plus) (K161416) and has an ASC feature for the MUA and MUA Plus using the Prosthetic Screw. In addition, the Prosthetic Screw MUA Omnigrip Mini features a DLC coating which is also featured in the abutment screws of the reference devices NobelZygoma 0° (Reference Device #3, K161598) and the Elos Accurate® Customized Abutment (Reference Device #4, K171799).
These different technological characteristics do not raise new concerns of substantial equivalence. The comparison table below (Table 005-2) for the NobelProcera Zirconia Implant Bridge (Subject device) to the NobelProcera HT ML FCZ Implant Bridge and Framework (Predicate Device) are substantially equivalent in terms of indication for use, technology and performance specifications as the few differences between the Subject Device and the Predicate Device do not impact substantial equivalence. The performance testing results provided in this submission supports that the Subject Device performs as well as the Predicate Devices for its intended use.
8
Table 005-2: Substantial Equivalence Table
| Device
characteristics | Subject Device | | Predicate Device:
K160158 | Reference Device
#1:
K143071 | Reference Device
#2:
K091907 | Reference Device
#3:
K161598 | Reference Device #4:
K171799 |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| NobelProcera Zirconia Implant
Bridge | NobelProcera Zirconia Implant
Bridge | | NobelProcera HT ML FCZ
Implant Bridge and
Framework | Nacera Pearl | NobelProcera
Implant Bridge
Zirconia | NobelZygoma 0° | Elos Accurate® Customized
Abutment |
| Pictorial
Representation | Image: Dental Bridge
(here shown with two Clinical Metal
Adapters) | | Image: FCZ Implant Bridge and
Framework | NA | NA | N/A | NA |
| | Image: Prosthetic Screw | Image: Clinical
Metal Adapter | Image: Clinical
Metal Adapter | | | | |
| Regulatory Classification | | | | | | | |
| Regulatory Class
Reg. Number
Classification Name | Class II
21 CFR 872.3630
Endosseous Dental
Implant Abutment | | Class II
21 CFR 872.3630
Endosseous Dental
Implant Abutment | Class II
21 CFR 872.6660
Porcelain Powder
for Clinical Use | Class II
21 CFR 872.3630
Endosseous Dental
Implant Abutment | Class II
21 CHR 872.3640
Endosseous Dental
Implant | Class II
21 CFR 872.3630
Endosseous Dental Implant
Abutment |
| Product code | NHA | | NHA | EIH | NHA | DZE, NHA | NHA |
| Indications for Use/Intended Use | | | | | | | |
| Indication for Use | The NobelProcera Zirconia 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 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. | Nacera Pearl blanks
are indicated for the
fabrication of single
crowns and
bridgework:
- fully anatomical
single crowns and
bridgework (FCZ) - Partially veneered
or fully veneered
crowns and bridges - Inlays, onlays, and
Maryland bridges - Primary telescopic
crowns for anterior
and posterior
applications | 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. | NobelZygoma
implants are
endosseous dental
implants intended to
be surgically placed
in the bone of the
upper jaw arch to
provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore patient
esthetics and
chewing function.
The NobelZygoma
Implants are
appropriate for
immediate loading
when good primary
stability is achieved
and with appropriate
occlusal loading. | The Elos Accurate® Customized
Abutments are intended for
attaching to dental implants in
order to provide basis for single
or multiple tooth prosthetic
restorations.
The Elos Accurate® Customized
Abutment will be attached to a
dental implant using the included
Elos Prosthetic screw.
The Elos Accurate® Customized
Abutments are compatible with
the following implant systems:
Nobel Biocare/Branemark RP,
3.75 & 4mm
Nobel Biocare/Branemark NP,
3.3mm
Nobel Biocare/Branemark WP,
5mm
All digitally designed Elos
Accurate® Customized
Abutments are intended to be
manufactured at an Elos
Medtech approved milling
facility. | |
| Intended use | The NobelProcera® Zirconia
Implant Bridges are customized
dental implant bridges. The implant
Bridge attaches directly to the
endosseous dental implants and/or
onto Nobel Biocare's Multi-unit
Abutments with prosthetic screws
and provides a platform for
restoration.
The NobelProcera® Zirconia
Implant Bridges are designed and
made individually to fit the individual
requirements for the patient.
NobelProcera® Zirconia Implant
Bridges are indicated for a bridge
span of 2 to up 14 units, on 2 up to
10 implants | The NobelProcera HT ML FCZ
Implant Bridge and Framework
are customized dental implant
bridges. The Implant Bridge
attaches directly to the
endosseous dental implants
and/or onto Nobel Biocare's
Multi-unit Abutments with
clinical screws and provides a
platform for restoration. | NA | NA | NA | NA | |
| Technological Characteristics | | | | | | | |
| Compatible
Implant/Abutment
and platform sizes | Nobel Biocare dental implants
connections: - Internal Conical
Connection:
NP, RP, WP - Internal Tri-Channel:
NP, RP, WP, 6.0 - External Hex: NP, RP, WP
Nobel Biocare dental abutment
and platform sizes:
- Multi-unit Abutment (MUA):
NP, RP, WP - Multi-unit Abutment (MUA)
Plus:
NP, RP, WP | Nobel Biocare dental implants
connections: - Internal Conical
Connection:
NP, RP, WP - Internal Tri-Channel:
NP, RP, WP, 6.0 - External Hex: NP, RP,
WP
Nobel Biocare dental abutment
and platform sizes:
- Multi-unit Abutment
(MUA):
NP, RP, WP | NA | NA | NA | NA | |
| Device Material | Zirconium Oxide:
Yttria-stabilized tetragonal
zirconia (Y-TZP)
Titanium vanadium alloy | Zirconium Oxide
Titanium vanadium alloy | Zirconium Oxide:
Yttria-stabilized
tetragonal zirconia
(Y-TZP)
NA | Zirconium Oxide
NA | NA
Titanium vanadium
alloy | NA
Titanium vanadium alloy | |
| Surface | Anodization:
Clinical Metal Adapter - for Internal
Conical Connection implants
DLC (Diamond Like Carbon)
coating: Prosthetic Screw MUA
Omnigrip Mini | Anodization:
Clinical Metal Adapter - for
Internal Conical Connection
implants | NA | NA | DLC (Diamond Like
Carbon) coating:
Abutment screw | DLC (Diamond Like Carbon)
coating (MediCarb):
Elos Abutment screws | |
| Bridge Design
(restoration type) | Individualized full anatomic contour
or framework | Individualized full anatomic
contour or framework | NA | NA | NA | NA | |
| Bridge Design:
Arc Length | 2 to 14 units | 2 to 14 units | NA | NA | NA | NA | |
| Number of Implants
per Dental Bridge | 2 to 10 implants | 2 to 14 implants | NA | NA | NA | NA | |
| Bridge Design:
Angulated Screw
Channel (ASC) | ASC CC: ASC feature available
when the Dental Bridge is used in
combination with Conical
Connection implants.
ASC MUA: ASC feature available
when Dental Bridge is used in | ASC CC: ASC feature
available when the Dental
Bridge is used in combination
with Conical Connection
implants | NA | N/A | NA | NA | |
| | combination with MUA and MUA
plus Abutments. | | | | | | |
| Angulated Screw
Channel (ASC):
Angulation | Screw Channel Angulation
between 0° to 25° | Screw Channel Angulation
between 0° to 25° | NA | N/A | NA | NA | |
| Design method | CAD | CAD | NA | N/A | NA | NA | |
| Manufacturing
method | Dental Bridge:
Industrialized manufacturing at
NobelProcera manufacturing facility | FCZ Implant Bridge:
Industrialized manufacturing at
NobelProcera manufacturing
facility | NA | N/A | NA | NA | |
| | Clinical Metal Adaptors and
Prosthetic Screws: Machined | Clinical Metal Adaptors:
Machined | NA | N/A | NA | NA | |
| Performance Testing | | | | | | | |
| Fatigue Performance | Fatigue testing using a modified
version of ISO 14801. | Fatigue testing using a
modified version of ISO 14801. | NA | N/A | Fatigue testing using
a modified version of
ISO 14801. | NA | |
| Biocompatibility | Biocompatible according to
ISO 10993-1:2018 | Biocompatible according to
ISO 10993-1:2009 | NA | N/A | Biocompatible
according to
ISO 10993-1:2018 | NA | |
9
10
11
12
005-07 Performance Data
The fatigue limit of the Subject and Predicate Device was determined using a modified version of ISO 14801 (in saline solution) to reflect the clinical loading on bridges. Fatigue performance test was performed following the worst-case assessment. The Dental Bridge was manufactured from the Reference Device #1 Nacera Pearl (K143071), using the new connection with a MUA Plus as well as the Prosthetic Screw.
The differences in surface finish of the Prosthetic Screw were further supported by evaluation of the subject device according to FDA guidance for Industry and FDA Staff "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" dated May 12, 2004 to support substantial equivalence to the DLC coated abutment screw reference device.
A biocompatibility evaluation was conducted according to ISO 10993 – 1. The results demonstrated that biocompatibility testing consisting of cytotoxicity and chemical characterization using GC-MS analysis is appropriate to assess the biological safety of the subject device. Test samples are representative of the finish subject device as they are made from the same material, manufacturing environments, and specifications as the subject device. The results demonstrate the biocompatibility of the subject device.
The subject device is provided non-sterile and is intended for single use only. The bridge and prosthetic screws are intended to be cleaned and sterilized prior to use. Validation for the cleaning and sterilization of the dental bridge and for the prosthetic screw was conducted. Sterilization validation was conducted per ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.
Both the Subject and Predicate Devices 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.
No clinical data was used to support the decision of Substantial Equivalence.
005-08 Conclusion
Based on a comparison of intended use, indications, technological characteristics, principle of operation, features and performance data, the NobelProcera Zirconia Implant Bridge is deemed to be substantially equivalent to the Predicate Device.