NobelParallel Conical Connection

K173418 · Nobel Biocare AB · DZE · Feb 21, 2019 · Dental

Device Facts

• Record ID: K173418
• Device Name: NobelParallel Conical Connection
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Feb 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

Device Story

Threaded, root-form, endosseous dental implants; surgically placed in jaw bone to anchor/support tooth replacements. Inputs: surgical site in patient jaw. Operation: mechanical anchoring via threaded design; conical connection for abutment interface. Output: stable base for prosthetic restoration. Used in dental clinics by trained clinicians. Benefits: restores patient esthetics and chewing function. Features: commercially pure titanium (ASTM F67-13); color-coded conical connections; 6.5–17.5 mm lengths; 3.75–5.5 mm diameters. Includes titanium alloy cover screws (Ti-6Al-4V).

Clinical Evidence

Retrospective multi-center single cohort clinical study provided for short implants (<7mm). Non-clinical evidence includes comparative fatigue testing (ISO 14801), surface area analysis, sterilization validation (ISO 11137), packaging/transport validation (ISO 11607), shelf-life (ASTM F1980), and endotoxin testing (USP <161>, ANSI/AAMI ST72).

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67-13) implant; Ti-6Al-4V alloy cover screw (ASTM F136-13, ISO 5832-3). Design: Threaded, root-form, tapered body/apex with 4 apical cutting flutes. Connection: Internal conical, color-coded. Dimensions: 6.5–17.5 mm length; 3.75–5.5 mm diameter. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring single or multiple tooth restorations in the upper or lower jaw. Suitable for 1-stage or 2-stage surgical techniques with immediate, early, or delayed loading protocols. Implants <7mm length restricted to delayed loading only.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• NobelActive® (K142660)

Reference Devices

• GROOVY IMPLANTS (K050258)
• LEGACY3 6MM LENGTH IMPLANTS (K131097)
• NobelSpeedy Groovy (K160119)

Submission Summary (Full Text)

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February 21, 2019

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K173418

Trade/Device Name: NobelParallel™ Conical Connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 21, 2019 Received: January 22, 2019

### 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. 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting 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) K173418

Device Name NobelParallelTM Conical Connection

### Indications for Use (Describe)

NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### FOR FDA USE ONLY

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K173418

# 510(k) Summary

#### l. Submitter

Submitted by:

Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Head Regulatory Affairs, US/CAN Phone: [phone] x7830 Fax: [phone]

Submitted for:

Nobel Biocare AB Vastra Hamngatan 1 Goteburg, SE-411 17 Sweden

Date Prepared: February 21, 2019

#### II. Device

| Device Proprietary<br>Name: | NobelParallel™ Conical Connection |
|-----------------------------|-----------------------------------|
| Common or Usual<br>Name: | Endosseous Dental Implant |
| Classification Name: | Endosseous Dental Implants |
| Regulation Number: | 21 CFR 872.3640 |
| Product Code: | DZE |
| Device Classification | II |

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#### lll. Predicate Device

| | Device Name | Applicant | 510(k)<br>Number |
|----------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------|
| Primary<br>Predicate | NobelActive® | NOBEL BIOCARE AB | K142660 |
| Reference<br>Devices | GROOVY IMPLANTS<br>LEGACY3 6MM LENGTH IMPLANTS<br>NobelSpeedy Groovy | NOBEL BIOCARE AB<br>IMPLANT DIRECT SYBRON<br>MANUFACTURING LLC<br>NOBEL BIOCARE AB | K050258<br>K131097<br>K160119 |

The following device are referenced in the Substantial Equivalence Discussion

#### Device Description IV.

NobelParallel™ Conical Connection (herein referred to as NobelParallel™ CC) implants are threaded, root-form, endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore a patient's chewing function.

The sterile, single-use only implants, made of commercially pure titanium (ASTM F67-13), range in length from 6.5 – 17.5 mm (physical implant length) and are provided in four (4) diameters (Ø 3.75 mm, 4.3 mm, 5.0 mm, and 5.5 mm). The implants feature a conical connection which is compatible with Nobel Biocare's narrow platform (NP), regular platform (RP), and wide platform (WP) abutments. The conical connections are color coded to identify the compatible abutment platform(s).

Each implant is individually packaged and provided with its corresponding titanium alloy cover screw (Ti-6Al-4V, per ASTM F136-13 and ISO 5832-3).

#### V. Indications for Use

NobelParallel™ Conical Connection implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function.

NobelParallel™ Conical Connection implants are indicated for single or multiple restorations in splinted or non-splinted applications. This can be achieved by a 2stage or 1-stage surgical techniques in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

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Implants with <7mm length are for delayed loading only when appropriate stability has been achieved.

#### Comparison of Technological Characteristics VI.

The NobelParallel™ CC implants are similar to the predicate devices as follows:

- same implant/abutment connection type as the NobelActive Implant . (K142260), and
- same implant body design, including slightly tapered walls and tapered apex . with cutting flutes, as the NOBELSPEEDY™ Groovy Implants (K160119).

The NobelParallel™ CC implants are technologically different from the predicate devices as follows:

- . the longest length of the subject device NobelParallel™ CC is within the range of predicate device NOBELSPEEDY™ Groovy,
- . the smallest implant diameter of the subject device NobelParallel™ CC is within the range of the predicate device NobelSpeedy™ Groovy implants, and
- the use of new drill protocols is required.

Comparisons of the subject and predicate implants and cover screws are provided in the following tables.

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### Comparison of Indications for Use Statements

| ATTRIBUTE | Subject Device | Primary Predicate | Reference Device | | Reference device |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Nobel Biocare | Nobel Biocare | Nobel Biocare | Implant Direct |
| | NobelParallel™<br>Conical Connection | NobelActive®<br>(K142260) | NobelSpeedy®<br>Groovy (K160119) | NobelReplace MK III<br>Groovy (K050258) | Legacy3 6mm<br>(K131097) |
| Indications for<br>Use | NobelParallel™<br>Conical Connection<br>implants are<br>endosseous implants<br>intended to be<br>surgically placed in the<br>upper or lower jaw<br>bone for anchoring or<br>supporting tooth<br>replacements to<br>restore patient<br>esthetics and chewing<br>function. | NobelActive® implants<br>are endosseous<br>implants intended to be<br>surgically placed in the<br>upper or lower jaw<br>bone for anchoring or<br>supporting tooth<br>replacements to<br>restore patient<br>esthetics and chewing<br>function.<br>NobelActive® implants<br>are indicated for single<br>or multiple unit<br>restorations in splinted<br>or non-splinted<br>applications. This can<br>be achieved by a 2-<br>stage or 1-stage<br>surgical technique in<br>combination with<br>immediate, early or<br>delayed loading<br>protocols, recognizing<br>sufficient primary | NobelSpeedy® Groovy<br>implants are<br>endosseous implants<br>intended to be<br>surgically placed in the<br>upper or lower jaw<br>bone for anchoring or<br>supporting tooth<br>replacements to<br>restore patient<br>esthetics and chewing<br>function.<br>NobelSpeedy® Groovy<br>implants are indicated<br>for single or multiple<br>unit restorations in<br>splinted or non-splinted<br>applications. This can<br>be achieved by a 2-<br>stage or 1-stage<br>surgical technique in<br>combination with<br>immediate, early or<br>delayed loading<br>protocols recognizing | Nobel Biocare's<br>Groovy Implants are<br>root-form endosseous<br>implants intended to be<br>surgically placed in the<br>bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices,<br>such as an artificial<br>tooth, in order to<br>restore patient<br>esthetics and chewing<br>function.<br>Nobel Biocare's<br>Groovy Implants are<br>indicated for single or<br>multiple unit<br>restorations in splinted<br>or non-splinted<br>applications.<br>Nobel Biocare Groovy<br>Implants may be<br>placed immediately | The Legacy Dental<br>Implant is a dental<br>implant fixture that is a<br>part of a two-piece<br>implant system. The<br>legacy implants are<br>intended for use in the<br>mandible and maxilla,<br>in support of single or<br>multiple-unit cement or<br>screw receiving fixed<br>restorations and for<br>retention and support<br>of overdentures. The<br>implants are intended<br>for immediate<br>placement and function<br>for support of single<br>tooth and/or multiple<br>tooth restorations,<br>recognizing bone<br>stability and<br>appropriate occlusal<br>load requirements. |

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| delayed loading<br>protocols, recognizing<br>sufficient primary<br>stability and<br>appropriate occlusal<br>loading for the selected<br>technique.<br>Implants with < 7mm<br>length are for delayed<br>loading only when<br>appropriate stability<br>has been achieved. | stability and<br>appropriate occlusal<br>loading for the selected<br>technique.<br>NobelActive® 3.0<br>implants are intended<br>to replace a lateral<br>incisor in the maxilla<br>and/or a central or<br>lateral incisor in the<br>mandible.<br>NobelActive® 3.0<br>implants are indicated<br>for single unit<br>restorations only. | sufficient primary<br>stability and<br>appropriate occlusal<br>loading for the selected<br>technique. Implants<br>allow also for bicortical<br>anchorage in cases of<br>reduced bone density.<br>NobelSpeedy® Groovy<br>implants 20, 22, 25 mm<br>when placed in the<br>maxilla are only<br>indicated for multiple<br>unit restorations in<br>splinted applications<br>that utilize at least two<br>implants. | and put into immediate<br>function providing that<br>the initial stability<br>requirements detailed<br>in the surgical manuals<br>are satisfied.<br>Groovy implants are<br>indicated for use in soft<br>bone in posterior<br>regions whenever<br>immediate or early<br>loading is applied. The<br>Groovy implants<br>incorporate a groove<br>on the implant thread<br>and are preferred over<br>models without the<br>groove in these soft<br>bone indications<br>because bone forms<br>more rapidly in the<br>groove than on other<br>parts of the implant<br>resulting in increased<br>stability when<br>compared to non-<br>grooved implants |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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# Comparison of Key Technological Characteristics

| ATTRIBUTE | Subject Device | Primary<br>Predicate<br>Nobel Biocare -1 | Reference device<br>- 2<br>Nobel Biocare | Reference device<br>- 3<br>Nobel Biocare | Reference device<br>- 4<br>Implant Direct | Comments |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | NobelParallel™<br>Conical<br>Connection | NobelActive®<br>(K142260) | NobelSpeedy®<br>Groovy (K160119)<br>incl. K050406 | NobelReplace MK<br>III Groovy<br>(K050258) | Legacy3 6mm<br>Length Implants<br>(K131097) | |
| Thread<br>Design | Double lead<br>thread with groove | Double lead<br>thread<br>Reverse cutting<br>flutes | Single lead thread<br>with groove | Double lead<br>thread with<br>grooves | Double lead<br>threaded | Double thread<br>same as 1<br>Groove same as 2<br>Groove Same as 2 |
| Connection<br>Type | Internal Conical* | Internal Hex | External Hex | Internal Tri-<br>channel | Leading bevel, a<br>hex and a 1-<br>72UNF thread | Same as 1 |
| Implant Body<br>Design | Tapered apex with<br>bone cutting flutes,<br>slightly tapered<br>body | Expanding Taper<br>Drilling blades on<br>apex | Tapered apex with<br>bone cutting flutes,<br>slightly tapered<br>body | Straight body<br>design based on<br>the Branemark Mk<br>III Groovy. Slightly<br>tapered apex but<br>not like Speedy | Tapered body | Same as 2 |
| Cutting Flutes | 4 apical flutes | 2 conical helix-<br>shaped flutes, 1/3<br>turns (120°) | 4 apical flutes | 3 apical flutes | Unknown+ | Same as 2 |
| Implant length<br>and diameter<br>(physical<br>dimensions) | $Ø$ 3.75mm: 6.5,<br>8.0, 9.5, 11.0,<br>12.5, 14.5, 17.5<br>mm | $Ø$ 3.5mm: 8.0, 9.5,<br>11.0, 12.5, 14.5,<br>17.5 mm | Speedy replace: $Ø$<br>3.5mm: 10.25,<br>11.75, 13.25,<br>15.25, | $Ø$ 3.5mm: 9.25,<br>10.75, 12.25,<br>14.25 mm | $Ø$ 3.7mm: 6mm; | Length:<br>• Min length:<br>6.5 mm longer<br>than 4<br>• other lengths<br>same as 1 |
| | | | | | | Diameter:<br>• Larger than<br>1,2,3<br>• Slightly<br>smaller than 4 |
| Ø 4.3mm: 6.5,<br>8.0, 9.5, 11.0,<br>12.5, 14.5, 17.5<br>mm | Ø 4.3mm: 8.0,<br>9.5, 11.0, 12.5,<br>14.5, 17.5 mm | Ø 4.0mm: 7.25,<br>8.75, 10.25, 11.75,<br>13.25, 15.25,<br>18.25, 20.25,<br>22.25, 25.25 mm | Ø 4.0mm: 9.25,<br>10.75, 12.25,<br>14.25, 17.25 mm | Ø 4.2mm: 6mm; | | Length:<br>• Min length:<br>6.5 mm longer<br>than 4<br>• other lengths<br>same as 1<br>Diameter:<br>• Larger/Same<br>as 1, 2, 3, 4 |
| Ø 5.0mm: 6.5,<br>8.0, 9.5, 11.0,<br>12.5, 14.5, 17.5<br>mm | Ø 5.0mm: 8.0,<br>9.5, 11.0, 12.5,<br>14.5, 17.5 mm | Ø 5.0mm: 7.25,<br>8.75, 10.25, 11.75,<br>13.25, 15.25,<br>18.25 mm | | Ø 4.7mm: 6mm;<br>Ø 5.2mm: 6mm; | | Length:<br>• Min length:<br>longer than 4<br>• other lengths<br>same as 1<br>Diameter:<br>• Larger/Same<br>as 1, 2, 4 |
| Ø 5.5mm: 6.5,<br>8.0, 9.5, 11.0,<br>12.5, 14.5 mm | Ø 5.5mm: 6.5,<br>8.0, 9.5, 11.0, 12.5<br>mm | Ø 6.0mm: 7.25,<br>8.75, 10.25, 11.75,<br>13.25, 15.25,<br>18.25 mm | Ø 5.0mm: 9.25,<br>10.75, 12.25,<br>14.25, 17.25 mm | Ø 5.7mm: 6mm;<br>Ø 7.0mm: 6mm; | | Length:<br>• Max length<br>smaller than<br>2,3<br>• Other lengths<br>same as 1<br>Diameter: |
| | | | | | | • Larger/Same<br>as 1, 3 |
| Implant<br>Diameter | 3.75, 4.3, 5.0, 5.5<br>mm | 3.5, 4.3, 5.0, 5.5<br>mm | 3.5, 4.0, 5.0, 6.0<br>mm | 3.5, 4.0, 5.0 mm | 3.7, 4.2, 4.7, 5.2,<br>5.7, 7.0 mm | Different – see<br>discussion |
| Connector<br>Color | Magenta - Ø 3.75<br>mm NP<br>Yellow - Ø 4.3<br>mm RP<br>Yellow - Ø 5.0<br>mm RP<br>Blue - Ø 5.5 mm<br>WP | Magenta - Ø 3.5<br>mm NP<br>Yellow - Ø 4.3<br>mm RP<br>Yellow - Ø 5.0<br>mm RP<br>Blue - Ø 5.5 mm<br>WP | N/A | Magenta - Ø 3.5<br>mm NP<br>Yellow - Ø 4.0<br>mm RP<br>Blue - Ø 5.0 mm<br>WP | Unknown+ | Same |
| Compatible<br>Abutments | Internal conical<br>connection:<br>NP Ø 3.0 mm<br>RP Ø 3.4 mm<br>WP Ø 4.4 mm | Internal conical<br>connection:<br>NP Ø 3.0 mm<br>RP Ø 3.4 mm<br>WP Ø 4.4 mm | External hex<br>connection<br>NP, RP, WP | Internal Tri-<br>channel: NP, RP,<br>WP | Unknown+ | Same as 1 |
| | K071370: Esthetic<br>Abutment Conical<br>Connection,<br>Narrow Profile<br>Abutment Conical<br>Connection<br>K072129:<br>Procera® Esthetic<br>Abutment Conical<br>Connection<br>K083100:<br>GoldAdapt™ Non-<br>Engaging Conical<br>Connection | K071370: Esthetic<br>Abutment Conical<br>Connection,<br>Narrow Profile<br>Abutment Conical<br>Connection<br>K072129:<br>Procera® Esthetic<br>Abutment Conical<br>Connection<br>K083100:<br>GoldAdapt™ Non-<br>Engaging Conical<br>Connection | | | Unknown+ | Same as 1 |

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# NobelParallel™ Conical Connection (CC) Traditional 510(k)

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# NobelParallel™ Conical Connection (CC) Traditional 510(k)

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* Previously named Internal Hex

+Unknown based on 510(k) summary

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# Comparison of Cover Screws

| ATTRIBUTE | Subject device | Primary Predicate | Comments |
|-----------|--------------------------------|--------------------------------|----------|
| | NobelParallel™ CC | NobelActive® (K142260) | |
| Design | Image: NobelParallel CC design | Image: NobelActive design | |
| Material | Ti6Al4V | Ti6Al4V | Same |
| Surface | Anodization | Machined surface / Anodization | Same |

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### Discussion

As seen above, the NobelParallel™ CC implant has the same internal conical connection (previously named Internal Hex) as the NobelActive Implants (K142260). Both the subject and the predicate devices are made of pure titanium and share the same TiUnite surface. Furthermore, the NobelParallel™ CC implant body follows the same design principles as the NOBELSPEEDY™ Groovy Implants (K160119), including the slightly tapered body and tapered apex with cutting flutes. The difference between the NobelParallel™ CC implants and the predicates is the availability of slightly larger outer diameters in the implants with diameters below 5.0 mm. The diameters are within the existing range of cleared implant diameters NobelActive implant (K142260) and Legacy3 6mm (K131097). Therefore, this difference does not raise questions substantial equivalence.

NobelParallel™ CC implant indications for use differ to the predicate device NobelActive Implants (K142260) in:

- Inclusion of a specific for short implants (< 7 mm) statement on limitations of loading protocols, which is not applicable to the predicate device as it is not available in length < 7 mm. The reference device Legacy3 6mm (K131097) indications for use include a similar statement on recognizing bone stability and appropriate occlusal load requirements.
- . Exclusion of language regarding 3.0 diameter implants as the subject device is not available in 3.0 diameter.

The subject cover screws are made of the same material as the predicate and have slightly different geometry. Their surface is color coded, using an anodization technique, to identify the compatible implants.

#### VII. Performance Data

The following safety and performance data were provided in support of the substantial equivalence determination:

- a. Clinical:
- retrospective multi-center single cohort clinical study on NobelParallel . Conical Connection short implant (<7mm).
- b. Non-clinical:
- comparative fatigue testing in accordance with ISO 14801; .
- comparative surface area analysis for short implants (<7 mm); .
- sterilization validation in accordance with ISO 11137-1:2006 + Amd 1:2013 . and EN ISO 11137-2:2013;
- packaging and transport validation in accordance with ISO 11607-1:2009 + ● Amd 1:2014;

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- shelf-life studies in accordance with: .
- ASTM F1980-2016 Standard Guide for Accelerated Aging of Sterile O Barrier Systems for Medical Devices
- endotoxin testing in accordance with: ●
- o USP <161 Medical Devices-Bacterial Endotoxin and Pyrogen Tests
- o ANSI/AAMI ST72:2011/ (R)2016 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing

#### VIII. Conclusion

The technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. As seen above, the NobelParallel™ CC is the same or similar to the predicate devices in terms of intended use, materials of construction, design, size, surface treatment, and sterilization. The data within this submission support that the NobelParallel™ CC is substantially equivalent to the identified predicate/references devices.

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