Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions CAD/CAM technology for design and manufacturing, which is standard digital dentistry workflow and does not inherently involve AI/ML. There is no mention of AI, ML, or related concepts in the document.

Therapeutic

No
The device is a restorative suprastructure for dental implants, described as restoring function, which falls under the category of prosthetics rather than actively treating a disease or condition.

Diagnostic

No

This device is a custom restorative device intended to facilitate prosthetic restoration, not to diagnose a condition. It is used for treatment, not diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device is a physical, custom-fabricated restorative device (implant suprastructure) designed using CAD/CAM technology, not a software-only medical device. The description explicitly mentions fabrication and physical testing.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to restore function in partially or totally edentulous jaws by attaching to dental implants or abutments. This is a restorative dental device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
Device Description: The device is described as a "custom restorative device" fabricated using CAD/CAM based on patient dental models and clinician prescriptions. This aligns with a custom-made dental prosthesis.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the ATLANTIS™ ISUS implant suprastructures fall under the category of a dental prosthetic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

ATLANTISTM 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.

ATLANTISTM 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 degrees and 45 degrees 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

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

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.

ATLANTISTM ISUS is available in four design types.

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
1. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
1. Hybrid Intended as a fixed denture framework.
1. 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 degrees 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 degrees angle. ASA screws are available for all compatible implant systems. (See Indications for Use Statement for compatible implant systems.)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

jaws

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122424, K090069, K131644, K133377

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure in profile, with three faces overlapping to represent the department's focus on health and human well-being. The emblem is simple and modern in design.

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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

2

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)

3

Image /page/3/Picture/0 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, creating a solid block of text.

510(k) SUMMARY for ATLANTISTM ISUS

DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 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

1. 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
(Primary Predicate Device)	K122424	DENTSPLY International Inc.
Procera Implant Bridge
Overdenture	K090069	Nobel Biocare USA, LLC
ANKYLOS SynCone
Abutment 5°	K131644	DENTSPLY International Inc.
NobelProcera Angulated Screw
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.

4

ATLANTISTM ISUS is available in four design types.

1. Bar Intended as a fixed supporting structure for a removable dental prosthesis.
1. Bridge Intended for direct veneering using dental ceramics or resin composites resulting in a fixed, screw-retained prosthesis.
1. Hybrid Intended as a fixed denture framework.
1. 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 ●

5

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
International Inc.	DENTSPLY
International Inc.	Nobel Biocare USA,
LLC	DENTSPLY
International Inc.	Nobel Biocare USA,
LLC
	Atlantis™ ISUS	ISUS Implant
Suprastructures	Procera Implant Bridge
Overdenture	ANKYLOS SynCone
Abutment 5°	NobelProcera
Angulated Screw
Channel Abutment
Replace
		K122424	K090069	K131644	K133377
Indications
for 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.	The 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. The ISUS
Implant
Suprastructures are
intended for	The Procera Implant
Bridge Overdenture is
indicated for use as an
overdenture bar that
attaches to implants or
abutments in the
treatment of partially or
totally edentulous jaws
for the purpose of
restoring chewing
function.	Anchorage of dentures
retained by taper
friction and supported
by ANKYLOS
implants.
Immediate loading of
an implant supported
prosthesis in an
edentulous mandible
supported by 4
ANKYLOS implants of
at least 11mm in length
and placed	The NobelProcera
Angulated Screw
Channel Abutment
Replace are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as an
aid in prosthetic
rehabilitation.
Table 6.1
	Subject Device		Predicate Devices
	DENTSPLY
International Inc.	DENTSPLY
International Inc.	Nobel Biocare USA,
LLC	DENTSPLY
International Inc.	Nobel Biocare USA,
LLC
	Atlantis™ ISUS	ISUS Implant
Suprastructures
K122424	Procera Implant Bridge
Overdenture
K090069	ANKYLOS SynCone
Abutment 5°
K131644	NobelProcera
Angulated Screw
Channel Abutment
Replace
K133377
	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 | attachment to a
minimum of two (2)
implants.

ISUS Implant
Suprastructures are
indicated for
compatibility with the
following implant and
abutment systems:

Implants:
• Nobel Biocare
Replace Select: NP
(3.5mm), RP
(4.3mm), WP
(5.0mm), and
Replace Select
6.0mm
• Nobel Biocare
Active Internal: NP
(3.5mm), RP
(4.3mm, 5.0mm)
• Zimmer Screw Vent: | | interforaminally. | |
| Table 6.1 | | | | | |
| | Subject Device | | Predicate Devices | | |
| | DENTSPLY
International Inc.
Atlantis™ ISUS | DENTSPLY
International Inc.
ISUS Implant
Suprastructures
K122424 | Nobel Biocare USA,
LLC
Procera Implant Bridge
Overdenture
K090069 | DENTSPLY
International Inc.
ANKYLOS SynCone
Abutment 5°
K131644 | Nobel Biocare USA,
LLC
NobelProcera
Angulated Screw
Channel Abutment
Replace
K133377 |
| | Replace Select: NP
(3.5mm), RP
(4.3mm), WP
(5.0mm) and
Replace Select 6.0 mm
• 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 | 1D3.5, D4.5, D5.7
• Straumann: NN
(3.5mm), RN
(4.8mm), WN
(6.0mm)
• Straumann Bone
Level: NC (3.3mm),
RC (4.1 mm,
4.8mm)
• 3i Internal
Connection: D3.4,
D4.1, D5, D6
• Friadent XiVE S:
D3, D3.4, D3.8,
D4.5, D5.5
Abutments:
• Astra Tech- 20° and
45° UniAbutment
• Astra Tech
UniAbutmnent EV:
3.6
• ANKYLOS Balance
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
Suprastructures | Procera Implant Bridge
Overdenture | ANKYLOS SynCone
Abutment 5° | NobelProcera
Angulated Screw
Channel Abutment | |
| | K122424 | K090069 | K131644 | Replace
K133377 | |
| 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 | and Narrow
Abutment D4.2
• Nobel Biocare Multi
-Unit Abutment RP:
4.0 mm
• Zimmer Tapered
Abutment: 4.5mm
• Straumann
RN(4.8mm), WN
(6.5 mm)
• Straumann Bone
Level: Multi-Base
Abutment D3.5,
D4.5
• Straumann Bone
Level Angled
Abutment:4.0 mm
• 3i Low Profile
Abutment
• Friadent XiVE MP
D3.8, D4.5, D5.5
• Friadent XiVE TG
D3.8, D4.5, D5.5 | | | | |

6

7

8

9

Table 6.1
	Subject Device	Predicate Devices
	DENTSPLY
International Inc.

Atlantis™ ISUS | DENTSPLY
International Inc.

ISUS Implant
Suprastructures
K122424 | Nobel Biocare USA, LLC

Procera Implant Bridge
Overdenture
K090069 | DENTSPLY
International Inc.

ANKYLOS SynCone
Abutment 5°
K131644 | Nobel Biocare USA, LLC

Atlantis™ ISUS | DENTSPLY
International Inc.

ISUS Implant
Suprastructures

K122424 | Nobel Biocare USA,
LLC

Procera Implant Bridge
Overdenture

K090069 | DENTSPLY
International Inc.

ANKYLOS SynCone
Abutment 5°

K131644 | Nobel Biocare USA,
LLC

NobelProcera
Angulated Screw
Channel Abutment
Replace
K133377 |
| Reason for
adding the
predicate
device | Subject Device | Primary Predicate
Device | In this reference
predicate device the 20
mm cantilever was
introduced. In the
Subject Device the
cantilever is 15 mm. | In this reference
predicate device the
conical connection was
introduced and it is a
predicate for the
Friction-Fit concept for
the 2in1 product
described in the Subject
Device. | In this reference
predicate device the
Angulated Screw
Access was
introduced and it is a
predicate for that
feature in the Subject
Device. |

10

11

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.