ATLANTIS ISUS

K151439 · Dentsply International, Inc. · NHA · Feb 19, 2016 · Dental

Device Facts

• Record ID: K151439
• Device Name: ATLANTIS ISUS
• Applicant: Dentsply International, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems: [List of compatible systems provided in document].

Device Story

ATLANTIS™ ISUS is a custom dental restorative device; facilitates prosthetic restoration for partially/totally edentulous patients. Device design derived from patient dental models; created by technicians using CAD software based on clinician prescription; fabricated via CAM milling. Available in four types: Bar (fixed support for removable prosthesis), Bridge (fixed, screw-retained), Hybrid (fixed denture framework), and 2-in-1 (fixed support with friction-fit secondary structure). Features Angulated Screw Access (ASA) allowing screw-channel placement up to 30° off-axis for esthetics/function. Used in dental clinics; operated by dental professionals. Output is a patient-specific suprastructure; aids in restoring chewing function and esthetics. Benefits include customized fit and improved prosthetic stability.

Clinical Evidence

No clinical performance data were submitted. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic compression-bending fatigue testing per ISO 14801 and screw torque testing.

Technological Characteristics

Custom-milled dental suprastructure. Materials: CPTi (Commercially Pure Titanium) or CoCr (Cobalt Chromium) alloy. Fabrication: CAD/CAM. Connection: Internal. Features: Straight or angulated screw access (up to 30°). Dimensions: Platform 3.0-6.5mm. Connectivity: None (standalone).

Indications for Use

Indicated for partially or totally edentulous patients requiring dental implant-supported prosthetic restoration. Requires attachment to a minimum of two dental implants or abutments. Compatible with specific 3i, Friadent, Nobel Biocare, Straumann, and Zimmer implant/abutment systems.

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

• ISUS Implant Suprastructures (K122424)
• Procera Implant Bridge Overdenture (K090069)
• ANKYLOS SynCone Abutment 5° (K131644)
• NobelProcera Angulated Screw Channel Abutment Replace (K133377)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Dentsply International, Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia St., Suite 60 York, Pennsylvania 17401

Re: K151439

Trade/Device Name: Atlantis™ ISUS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2016 Received: January 21, 2016

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4. INDICATIONS FOR USE STATEMENT

K151439 510(k) Number:

ATLANTISTM ISUS Device Name:

ATLANTISTM ISUS:

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

### Implants:

- 3i Internal Connection: D3.4, D4.1, D5, D6 ●
- Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5 ●
- . Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
- Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select 6.0mm
- Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm) ●
- . Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm)
- Zimmer Screw Vent: D3.5, D4.5, D5.7

### Abutments:

- 3i Low Profile Abutment ●
- ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2 ●
- ASTRA TECH 20° and 45° UniAbutment
- Astra Tech UniAbutment EV 3.6 ●
- . Friadent XiVE MP D3.8, D4.5, D5.5
- Friadent XiVE TG D3.8,D 4.5, D5.5 ●
- . Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
- Straumann Bone Level Angled Abutment: 4.0 mm ●
- Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
- Straumann RN (4.8 mm), WN (6.5 mm) ●
- . Zimmer Tapered Abutment: 4.5 mm

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) SUMMARY for ATLANTISTM ISUS

### DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 [phone] Fax [phone] www.dentsply.com

#### Submitter Information: 1.

DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60W York, PA 17401

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |

Date Prepared: 28 May 2015

- 2. Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Section: .
- Device Class: .
- . Product Code:

ATLANTISTM ISUS Endosseous dental implant abutment 21 CFR 872.3630 Class II NHA

#### 3. Predicate Devices:

The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices. The primary predicate device is K122424.

| Predicate Device Name | 510(k) | Company Name |
|------------------------------------------------------------|---------|-----------------------------|
| ISUS Implant Suprastructures<br>(Primary Predicate Device) | K122424 | DENTSPLY International Inc. |
| Procera Implant Bridge<br>Overdenture | K090069 | Nobel Biocare USA, LLC |
| ANKYLOS SynCone<br>Abutment 5° | K131644 | DENTSPLY International Inc. |
| NobelProcera Angulated Screw<br>Channel Abutment Replace | K133377 | Nobel Biocare USA, LLC |

#### 4. Description of Device:

ATLANTIS™ ISUS is a custom restorative device that is intended to dental implants or abutments to facilitate prosthetic restoration in the treatment of partially and totally edentulous patients. The design of the subject device is derived from patient dental models and completed by DENTSPLY technicians using computer-assisted design (CAD) according to the clinician's prescription. The final CAD design of ATLANTIS™ ISUS is fabricated using computer-assisted manufacturing (CAM) to produce a custom patient specific device.

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ATLANTISTM ISUS is available in four design types.

- 1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
- 2. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
- 3. Hybrid Intended as a fixed denture framework.
- 4. 2 in 1 Intended as a fixed supporting structure for a removable dental prosthesis in combination with a hybrid denture framework retained by friction fit. The primary structure is a non-standard bar configuration. The secondary structure is a bridge or hybrid denture restoration with a tapered friction fit connection rather than a screw-retained connection.

# Angulated Screw Access (Screws):

The purpose of Angulated Screw Access (ASA) is to place the position of the screw-channel opening in a non-visual area by changing the angulation of the screw-channel. ASA allows the prosthetic screw access channel to be angled up to 30° off the implant/abutment axis for optimal esthetics and function. ASA screws have a hexalobular driving feature in the screw head allowing the hexalobular screwdriver to engage the screw head at a 30° angle. ASA screws are available for all compatible implant systems. (See Indications for Use Statement for compatible implant systems.)

#### 5. Indications for Use:

# ATLANTISTM ISUS:

ATLANTIS™ ISUS implant suprastructures are indicated for attachment to dental implants or abutments in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

ATLANTIS™ ISUS implant suprastructures are intended for attachment to a minimum of two (2) implants and are indicated for compatibility with the following implant and abutment systems:

# Implants:

- 3i Internal Connection: D3.4, D4.1, D5, D6 ●
- Friadent XiVE S: D3.0, D3.4, D3.8, D4.5, D5.5
- Nobel Biocare Active Internal: NP (3.5mm), RP (4.3mm, 5.0mm)
- Nobel Biocare Replace Select: NP (3.5mm), RP (4.3mm), WP (5.0mm) and Replace Select ● 6.0mm
- Straumann Bone Level: NC (3.3mm), RC (4.1mm, 4.8mm)
- Straumann NN (3.5mm), RN (4.8mm), WN (6.0mm) ●
- . Zimmer Screw Vent: D3.5, D4.5, D5.7

# Abutments:

- 3i Low Profile Abutment ●
- ANKYLOS Balance Base Abutment D5.5 and Narrow Abutment D4.2
- ASTRA TECH 20° and 45° UniAbutment
- Astra Tech UniAbutment EV 3.6 ●
- Friadent XiVE MP D3.8. D4.5, D5.5
- Friadent XiVE TG D3.8,D 4.5, D5.5
- Nobel Biocare Multi-Unit Abutment RP: 4.0 mm
- . Straumann Bone Level Angled Abutment: 4.0 mm
- Straumann Bone Level: Multi-Base Abutment D3.5, D4.5
- Straumann RN (4.8 mm), WN (6.5 mm)
- Zimmer Tapered Abutment: 4.5 mm ●

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#### 6. Substantial Equivalence:

# Technological Characteristics.

ATLANTIS™ ISUS is a custom restorative device with the following technological characteristics equivalent to the predicate devices:

- Fabricated using computer-assisted design (CAD) according to the clinician's prescription. .
- Milled using computer-assisted manufacturing (CAM). .
- Fabricated from homogenous, single-block raw material (CPTi or CoCr alloy). .

Table 6.1 below describes the differences and similarities of the subject and predicate devices.

| Table 6.1 | | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Devices | | | |
| | DENTSPLY<br>International Inc. | DENTSPLY<br>International Inc. | Nobel Biocare USA,<br>LLC | DENTSPLY<br>International Inc. | Nobel Biocare USA,<br>LLC |
| | Atlantis™ ISUS | ISUS Implant<br>Suprastructures | Procera Implant Bridge<br>Overdenture | ANKYLOS SynCone<br>Abutment 5° | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace |
| | | K122424 | K090069 | K131644 | K133377 |
| Indications<br>for Use | ATLANTIS™ ISUS<br>implant<br>suprastructures are<br>indicated for<br>attachment to dental<br>implants or<br>abutments in the<br>treatment of partially<br>or totally edentulous<br>jaws for the purpose<br>of restoring chewing<br>function. | The ISUS Implant<br>Suprastructures are<br>indicated for<br>attachment to dental<br>implants or abutments<br>in the treatment of<br>partially or totally<br>edentulous jaws for<br>the purpose of<br>restoring chewing<br>function. The ISUS<br>Implant<br>Suprastructures are<br>intended for | The Procera Implant<br>Bridge Overdenture is<br>indicated for use as an<br>overdenture bar that<br>attaches to implants or<br>abutments in the<br>treatment of partially or<br>totally edentulous jaws<br>for the purpose of<br>restoring chewing<br>function. | Anchorage of dentures<br>retained by taper<br>friction and supported<br>by ANKYLOS<br>implants.<br>Immediate loading of<br>an implant supported<br>prosthesis in an<br>edentulous mandible<br>supported by 4<br>ANKYLOS implants of<br>at least 11mm in length<br>and placed | The NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endosseous dental<br>implants and are<br>intended for use as an<br>aid in prosthetic<br>rehabilitation. |
| Table 6.1 | | | | | |
| | Subject Device | | Predicate Devices | | |
| | DENTSPLY<br>International Inc. | DENTSPLY<br>International Inc. | Nobel Biocare USA,<br>LLC | DENTSPLY<br>International Inc. | Nobel Biocare USA,<br>LLC |
| | Atlantis™ ISUS | ISUS Implant<br>Suprastructures<br>K122424 | Procera Implant Bridge<br>Overdenture<br>K090069 | ANKYLOS SynCone<br>Abutment 5°<br>K131644 | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace<br>K133377 |
| | implant<br>suprastructures are<br>intended for<br>attachment to a<br>minimum of two (2)<br>implants and are<br>indicated for<br>compatibility with the<br>following implant<br>and abutment<br>systems:<br><br>Implants:<br>• 3i Internal<br>Connection: D3.4,<br>D4.1, D5, D6<br>• Friadent XiVE S:<br>D3.0, D3.4, D3.8,<br>D4.5, D5.5<br>• Nobel Biocare<br>Active Internal: NP<br>(3.5mm), RP<br>(4.3mm, 5.0mm)<br>• Nobel Biocare | attachment to a<br>minimum of two (2)<br>implants.<br><br>ISUS Implant<br>Suprastructures are<br>indicated for<br>compatibility with the<br>following implant and<br>abutment systems:<br><br>Implants:<br>• Nobel Biocare<br>Replace Select: NP<br>(3.5mm), RP<br>(4.3mm), WP<br>(5.0mm), and<br>Replace Select<br>6.0mm<br>• Nobel Biocare<br>Active Internal: NP<br>(3.5mm), RP<br>(4.3mm, 5.0mm)<br>• Zimmer Screw Vent: | | interforaminally. | |
| Table 6.1 | | | | | |
| | Subject Device | | Predicate Devices | | |
| | DENTSPLY<br>International Inc.<br>Atlantis™ ISUS | DENTSPLY<br>International Inc.<br>ISUS Implant<br>Suprastructures<br>K122424 | Nobel Biocare USA,<br>LLC<br>Procera Implant Bridge<br>Overdenture<br>K090069 | DENTSPLY<br>International Inc.<br>ANKYLOS SynCone<br>Abutment 5°<br>K131644 | Nobel Biocare USA,<br>LLC<br>NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace<br>K133377 |
| | Replace Select: NP<br>(3.5mm), RP<br>(4.3mm), WP<br>(5.0mm) and<br>Replace Select 6.0 mm<br>• Straumann Bone<br>Level: NC (3.3mm), RC<br>(4.1mm, 4.8mm)<br>• Straumann NN<br>(3.5mm), RN<br>(4.8mm), WN<br>(6.0mm)<br>• Zimmer Screw<br>Vent: D3.5, D4.5,<br>D5.7<br>Abutments:<br>• 3i Low Profile<br>Abutment<br>• ANKYLOS Balance<br>Base Abutment D5.5<br>and Narrow | 1D3.5, D4.5, D5.7<br>• Straumann: NN<br>(3.5mm), RN<br>(4.8mm), WN<br>(6.0mm)<br>• Straumann Bone<br>Level: NC (3.3mm),<br>RC (4.1 mm,<br>4.8mm)<br>• 3i Internal<br>Connection: D3.4,<br>D4.1, D5, D6<br>• Friadent XiVE S:<br>D3, D3.4, D3.8,<br>D4.5, D5.5<br>Abutments:<br>• Astra Tech- 20° and<br>45° UniAbutment<br>• Astra Tech<br>UniAbutmnent EV:<br>3.6<br>• ANKYLOS Balance<br>Base Abutment D5.5 | | | |
| Table 6.1 | | | | | |
| Subject Device | | Predicate Devices | | | |
| DENTSPLY | DENTSPLY | Nobel Biocare USA, | DENTSPLY | Nobel Biocare USA, | |
| International Inc. | International Inc. | LLC | International Inc. | LLC | |
| Atlantis™ ISUS | ISUS Implant<br>Suprastructures | Procera Implant Bridge<br>Overdenture | ANKYLOS SynCone<br>Abutment 5° | NobelProcera<br>Angulated Screw<br>Channel Abutment | |
| | K122424 | K090069 | K131644 | Replace<br>K133377 | |
| Abutment D4.2<br>ASTRA TECH 20°<br>and 45°<br>UniAbutment<br>• Astra Tech<br>UniAbutment EV 3.6<br>· Friadent XiVE MP<br>D3.8, D4.5, D5.5<br>• Friadent XiVE TG<br>D3.8,D 4.5, D5.5<br>· Nobel Biocare Multi-<br>Unit Abutment RP:<br>4.0 mm<br>Straumann Bone<br>Level Angled<br>Abutment: 4.0 mm<br>Straumann Bone<br>Level: Multi-Base<br>Abutment D3.5.<br>D4.5<br>Straumann RN (4.8<br>mm), WN (6.5 mm)<br>Zimmer Tapered<br>Abutment: 4.5 mm | and Narrow<br>Abutment D4.2<br>• Nobel Biocare Multi<br>-Unit Abutment RP:<br>4.0 mm<br>• Zimmer Tapered<br>Abutment: 4.5mm<br>• Straumann<br>RN(4.8mm), WN<br>(6.5 mm)<br>• Straumann Bone<br>Level: Multi-Base<br>Abutment D3.5,<br>D4.5<br>• Straumann Bone<br>Level Angled<br>Abutment:4.0 mm<br>• 3i Low Profile<br>Abutment<br>• Friadent XiVE MP<br>D3.8, D4.5, D5.5<br>• Friadent XiVE TG<br>D3.8, D4.5, D5.5 | | | | |

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| Table 6.1 | | | | | |
|-------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Devices | | | |
| | DENTSPLY<br>International Inc.<br><br>Atlantis™ ISUS | DENTSPLY<br>International Inc.<br><br>ISUS Implant<br>Suprastructures<br>K122424 | Nobel Biocare USA, LLC<br><br>Procera Implant Bridge<br>Overdenture<br>K090069 | DENTSPLY<br>International Inc.<br><br>ANKYLOS SynCone<br>Abutment 5°<br>K131644 | Nobel Biocare USA, LLC<br><br>NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace<br>K133377 |
| Design | | | | | |
| Prosthesis<br>Attachment | Screw-retained,<br>Friction-fit | Screw-retained | Screw-retained | Friction-Fit | Screw-retained |
| Restoration | Multi-unit | Multi-unit | Multi-unit | Multi-unit | Single, Multi-unit |
| Platform<br>Diameter | 3.0 - 6.5 | 3.0 - 6.5 | 3.3 - 6.5 | 4.0 | 3.5-5.0 |
| Abutment<br>Angle | Straight,<br>up to 30° | Straight,<br>up to 30° | Straight | Straight,<br>up to 30° | Straight,<br>up to 59° |
| Screw<br>Access<br>Angle | Straight,<br>up to 30° | Straight | Straight | Straight | Straight,<br>up to 30° |
| Connection | Internal | Internal | Internal | Internal | Internal |
| Material | | | | | |
| Supra-<br>structure | Titanium, Cobalt<br>Chromium | Titanium, Cobalt<br>Chromium | Titanium alloy, Cobalt<br>Chromium | Gold alloy<br>(counterpart) | Titanium alloy |
| Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
| Table 6.1 | | Predicate Devices | | | |
| | Subject Device | | | | |
| | DENTSPLY<br>International Inc.<br><br>Atlantis™ ISUS | DENTSPLY<br>International Inc.<br><br>ISUS Implant<br>Suprastructures<br><br>K122424 | Nobel Biocare USA,<br>LLC<br><br>Procera Implant Bridge<br>Overdenture<br><br>K090069 | DENTSPLY<br>International Inc.<br><br>ANKYLOS SynCone<br>Abutment 5°<br><br>K131644 | Nobel Biocare USA,<br>LLC<br><br>NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Replace<br>K133377 |
| Reason for<br>adding the<br>predicate<br>device | Subject Device | Primary Predicate<br>Device | In this reference<br>predicate device the 20<br>mm cantilever was<br>introduced. In the<br>Subject Device the<br>cantilever is 15 mm. | In this reference<br>predicate device the<br>conical connection was<br>introduced and it is a<br>predicate for the<br>Friction-Fit concept for<br>the 2in1 product<br>described in the Subject<br>Device. | In this reference<br>predicate device the<br>Angulated Screw<br>Access was<br>introduced and it is a<br>predicate for that<br>feature in the Subject<br>Device. |

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# Biocompatibility

The results of biocompatibility testing conducted for the predicate device, ISUS Implant Suprastructures (K122424) are valid, therefore, no additional biocompatibility testing has been performed.

# Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included static and dynamic compression-bending testing according to ISO 14801 Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants (2007) and torque testing. This includes testing of the 2in1 design. Results of the fatigue testing support substantial equivalence in fatigue performance. Screw torque testing shows that sufficient torque can be applied in situations with angulated screw access.

No clinical performance data were submitted.

## Conclusion Regarding Substantial Equivalence

The data included in this submission demonstrate substantial equivalence to the predicate devices, ISUS Implant Suprastructures (K122424), Procera Implant Bridge Overdenture (K090069), ANKYLOS SynCone Abutment 5 (K131644) and NobelProcera Angulated Screw Channel Abutment Replace (K133377) listed above. The proposed device has the same intended use, is composed of the same or similar materials, and is characterized by the same fundamental product technology as the predicate devices, K122424, K090069, K131644 and K133377. Any differences in the technological characteristics between the subject and predicate devices do not raise different issues of safety or effectiveness.