Who is the manufacturer of NobelProcera Zirconia Implant Bridge?

Nobel Biocare AB filed the 510(k) submission for NobelProcera Zirconia Implant Bridge (K202452).

What is the FDA product code for NobelProcera Zirconia Implant Bridge?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for NobelProcera Zirconia Implant Bridge?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like NobelProcera Zirconia Implant Bridge?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NobelProcera Zirconia Implant Bridge

K202452 · Nobel Biocare AB · NHA · Dec 3, 2020 · Dental

Device Facts

Record ID	K202452
Device Name	NobelProcera Zirconia Implant Bridge
Applicant	Nobel Biocare AB
Product Code	NHA · Dental
Decision Date	Dec 3, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Patient-specific, screw-retained dental implant bridge; connects to root-form endosseous dental implants or Multi-unit abutments (MUA/MUA Plus). Designed in dental lab/clinic via CAD/CAM software and approved scanner; manufactured industrially at Nobel Biocare facility. Available as full-contour design or framework for veneering. Features angulated screw channel (ASC) (0°-25°). Used by dental professionals to restore chewing function in edentulous patients. Provides mechanical connection to 2-10 implants. Includes clinical/prosthetic screws; clinical metal adapters used for specific internal conical connections. Benefits patient by providing customized, stable dental restoration.

Clinical Evidence

No clinical data. Bench testing only. Fatigue testing performed using a modified version of ISO 14801 in saline solution. Biocompatibility evaluation conducted per ISO 10993-1, including cytotoxicity and chemical characterization (GC-MS). Cleaning and sterilization validation performed per ISO 17665-1, ISO 17665-2, ANSI/AAMI ST79, and ANSI/AAMI TIR 12.

Technological Characteristics

Material: Yttria-stabilized tetragonal zirconia (Y-TZP) and titanium vanadium alloy. Design: CAD/CAM patient-specific. Connections: Internal Conical, Internal Tri-Channel, External Hex, MUA/MUA Plus. Surface: Anodized adapters, DLC-coated prosthetic screws. Dimensions: 2-10 implants, 2-14 units. Sterilization: Non-sterile, requires user cleaning/sterilization. Standards: ISO 14801 (fatigue), ISO 10993-1 (biocompatibility), ISO 17665 (sterilization).

Indications for Use

Indicated for partially or totally edentulous patients requiring dental implant-supported bridge restoration to restore chewing function.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

NobelProcera HT ML FCZ Implant Bridge and Framework (K160158)

Reference Devices

Nacera Pearl (K143071)
NobelProcera Implant Bridge Zirconia (K091907)
NobelZygoma 0° (K161598)
Elos Accurate® Customized Abutment (K171799)

Related Devices

K160158 — NobelProcera HT ML FCZ Implant Bridge and Framework · Nobel Biocare AB · Jul 25, 2016
K240346 — NobelProcera Zirconia Implant Bridge · Nobel Biocare AB · Jan 3, 2025
K140737 — STRAUMANN CARES SCREW RETAINED BARS/BRIDGE · Straumann USA, LLC · Aug 14, 2014
K233208 — NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium · Nobel Biocare AB · Jan 24, 2024
K160207 — ATLANTIS ISUS Implant Suprastructures · Dentsply International, Inc. · Sep 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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) K202452 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {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. {6}------------------------------------------------ # 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 | {7}------------------------------------------------ #### 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…