Predicate Devices

Reference Devices

K031055, K200586, K213599, K172640, K161416, K052823

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a dental implant system, with no mention of AI or ML.

Therapeutic

Yes.
The device is a dental implant system used to support single or multiple-unit restorations, which are aimed at restoring the patient's total mouth function. This restorative function for the body qualifies it as therapeutic.

Diagnostic

No

The UNIdental Symphony Implant System is a dental implant system designed for surgical placement in the bone to support teeth restorations. Its function is to replace missing teeth and provide structural support, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4, which are hardware materials. The performance studies also focus on physical properties and sterilization, not software validation.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The UNIdental Symphony Implant System is a surgically implanted device made of titanium. Its purpose is to replace missing teeth and support dental restorations. It is placed directly into the bone of the jaw.

The device's function is mechanical and structural, not diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

Product codes

DZE, NHA

Device Description

The UNIdental Symphony Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. Symphony 1 Fixture is Bone level, and Symphony 2 Fixture is Tissue level.

Symphony 1 Fixture is a taper shape that gradually decreases the outer diameter of the lower part from the upper part.
And It is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. It is a structure that can perform a tapping function at the same time without a separate tap. It couples up with the abutment and its hexagon shape.

Symphony 2 Fixture is a structure with a round shape at the end. It couples up with the abutment and its octagon shape. The area that touches the patient's gums is pure titanium surface.

Implant Diameter:
Symphony 1 Fixture: 3.6, 4.0, 4.5, 5.0, 5.8mm
Symphony 2 Fixture: 3.3, 4.1, 4.8mm

Implant Length:
Symphony 1 Fixture: 7.0, 8.0, 10, 11.6, 12, 14mm
Symphony 2 Fixture: 9.35, 10.35, 12.35, 14.35, 15.35, 16.35, 17.35mm

The upper structure of the abutments support prosthetics such as artificial teeth to restore patient's total mouth function.

Healing Abutment:
Type: Symphony 1, Symphony 2
Description: The healing abutments provide the framework for soft tissue healing and stability, which can achieve the formation of an ideal emergence profile, prevent soft tissue from overgrowing over the implant fixture, and minimize the possibility of a second surgery.
Raw Material: Ti-6Al-4V ELI
Diameter: Symphony 1: 4.1, 4.5, 5.0, 5.5, 6.5, 7.5, 8.5, 9.5mm; Symphony 2: 5.5, 7.2mm
Length: Symphony 1: 9.5, 11, 12.5, 14.5mm; Symphony 2: 6.5, 7.5, 9, 10.5, 12.5mm

Straight Abutment:
Type: Symphony 1 (Dual Abutment)
Description: It is a general straight type superstructure. The dual abutment has the shape of an inner crown and is an abutment fixed with cement. The cemented abutment has the shape of an inner crown and is an abutment that fixes the prosthesis with dental cement, and the fixture and connection part are hex.
Raw Material: Ti-6Al-4V ELI
Diameter: 4.5, 5.5, 6.5mm
Length: 8.2, 9.2, 9.7, 10.7, 11.2, 11.7, 12.2, 12.7, 13.2, 13.7, 14.2, 15.2mm

Angled Abutment:
Type: Symphony 2 (Cemented Abutment), Symphony 1, Symphony 2
Description: It is used in case of the slope of the prosthesis where the upper part is not applicable. TiN coating has been applied to some items to prevent the metal color from appearing black on the gums. Angled Abutment combined with the Symphony 2 fixture has A type and B type, and the only difference between the two types is the direction when fastening. The allowed angulations are 15° and 25°.
Raw Material: Ti-6Al-4V ELI (TiN Coating for Symphony 1)
Diameter: Symphony 2 (Cemented Abutment): 3.5, 3.55, 4.3mm; Symphony 1: 4.5, 5.5mm; Symphony 2: 3.5, 4.3mm
Length: Symphony 2 (Cemented Abutment): 6.7, 8.2, 8.4mm; Symphony 1: 12.76, 12.89, 13.01, 13.30, 13.79, 13.89, 14.01, 14.30, 14.79, 14.89, 15.01, 15.30mm; Symphony 2: 5.5, 6.5mm

Multi-unit Straight Abutment:
Type: Multi-unit Straight Abutment
Description: This product is intended to be used by edentulous patients in the Overdenture case.
Raw Material: Ti-6Al-4V ELI
Diameter: 4.8mm
Length: 8.2, 9.2, 9.3, 10.3, 11.3, 12.3mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

partially or fully edentulous mandibles and maxillae

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)

Sterilization validating testing has been performed in accordance with ISO 11137 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
Shelf-life testing has been performed in according with ASTM F1980, ISO 11607, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and ISO 11737-2.
SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy) were performed to evaluate the fixture surface characteristics after SLA treatment.
Biocompatibility Tests were performed in accordance with ISO 10993-3, 5, 6, 10, and 11.
Compressive load and fatigue tests in accordance with ISO 14801
Bacterial Endotoxin Levels (LAL) in accordance with USP 85
MRI Safety: A non-clinical worst-case MRI review was conducted to evaluate the UNIdental Symphony Implant System in an MRI environment. Various dental journals were utilized to ensure its stability, and scientific evidence from literature was considered, such as the study by Yong-Ha Kim, Manki Choi, and Jae-Won Kim titled 'Are titanium implants actually safe for magnetic resonance imaging examinations?' The study concluded that titanium, being a paramagnetic material, is not affected by the magnetic field of MRI. The risk of implant-based complications is very low, and MRI can be safely used in patients with implants. Based on this paper, the stability of the raw material of the UNIdental Symphony Implant System in an MRI environment was confirmed. In the study conducted by Woods, Terry O., Jana G. Delfino, and Sunder Rajan titled 'Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices', Titanium Grade 4 was evaluated using magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119) tests by T. O. Woods et al. Based on this research, parameters per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" have been addressed.

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

Not Found

Predicate Device(s)

K160965

Reference Device(s)

K031055, K200586, K213599, K172640, K161416, K052823

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 25, 2023

UNIdental Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine. California 92612

Re: K221315

Trade/Device Name: UNIdental Symphony Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 29, 2023 Received: October 2, 2023

Dear Priscilla Chung:

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director

2

DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known)

K221315

Device Name UNIdental Symphony Implant System

Indications for Use (Describe)

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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4

510(k) Summary (K221315)

This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 10/19/2023

1. Submitter

UNIdental Co., Ltd. #D-613 GM Techno-park, 60 Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322, Korea

Tel: +82-2-898-8715 Fax: +82-2-897-8715

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c(@lkconsultinggroup.com

3. Device

Trade Name: UNIdental Symphony Implant System ●
Common Name: Dental Implant System
Classification Name: Endosseous Dental Implant
. Primary Product Code: DZE
Secondary Product Code: NHA
Classification regulation: 21CFR 872.3640

4. Predicate Device:

Primary Predicate Device: ● SuperLine by Dentium Co., Ltd. (K160965)
Reference Predicate Device: ● ITI Dental Implant System by Straumann (K031055) Straumann TLX Implant System by Straumann USA, LLC (K200586) SuperLine by Dentium Co., Ltd. (K213599) DentiumImplantium® &SuperLine® Prosthetics by Dentium Co., Ltd. (K172640)

5

Multi-unit Abutment Plus by NOBEL BIOCARE AB (K161416) IMPLANTIUM ABUTMENTS by DENTIUM, INC. (K052823)

5. Description:

The UNIdental Symphony Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. Symphony 1 Fixture is Bone level, and Symphony 2 Fixture is Tissue level.

Symphony 1 Fixture is a taper shape that gradually decreases the outer diameter of the lower part from the upper part.

And It is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. It is a structure that can perform a tapping function at the same time without a separate tap. It couples up with the abutment and its hexagon shape.

Symphony 2 Fixture is a structure with a round shape at the end. It couples up with the abutment and its octagon shape. The area that touches the patient's gums is pure titanium surface.

Implant Diameter	Symphony 1 Fixture	3.6, 4.0, 4.5, 5.0, 5.8mm
	Symphony 2 Fixture	3.3, 4.1, 4.8mm
Implant Length	Symphony 1 Fixture	7.0, 8.0, 10, 11.6, 12, 14mm
	Symphony 2 Fixture	9.35, 10.35, 12.35, 14.35, 15.35, 16.35, 17.35mm

The upper structure of the abutments support prosthetics such as artificial teeth to restore patient's total mouth function.

| Type | Description | Raw
Material | Diameter | Length | |
|----------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------|-----------------------------------------------------------------------------|
| Healing
Abutment | Symphony 1 | The healing abutments provide the
framework forsoft tissue healing
and stability, which can achieve
the formation of anideal
emergence profile, prevent soft | Ti-6Al-
4V ELI | 4.1, 4.5,
5.0, 5.5,
6.5, 7.5,
8.5,
9.5mm | 9.5, 11, 12.5,
14.5mm |
| | Symphony 2 | tissuefrom overgrowing over the
implant fixture, and minimize the
possibility of a second surgery. | Ti-6Al-
4V ELI | 5.5,
7.2mm | 6.5,7.5, 9,
10.5, 12.5mm |
| Straight
Abutment | Symphony 1
(Dual
Abutment) | It is a general straight type
superstructure.
The dual abutment has the shape
of an inner crown and is an
abutment fixed with cement. | Ti-6Al-
4V ELI | 4.5, 5.5,
6.5mm | 8.2, 9.2, 9.7,
10.7, 11.2,
11.7, 12.2,
12.7, 13.2,
13.7, 14.2mm |

510(k) summary

6

		The cemented abutment has the
Angled
Abutment	Symphony 2
(Cemented
Abutment)	shape of an innercrown and is an
abutment that fixes the prosthesis
with dental cement, and the fixture
and connection part are hex.	Ti-6Al-
4V ELI	3.5, 3.55,
4.3mm	6.7, 8.2,
8.4mm
	Symphony 1	It is used in case of the slope of
the prosthesis where the upper
part is not applicable.
TiN coating has been applied to
some items to prevent the metal
color from appearing black on the
gums.	Ti-6Al-
4V ELI
(TiN
Coating)	4.5,
5.5mm	12.76, 12.89,
13.01, 13.30,
13.79, 13.89,
14.01, 14.30,
14.79, 14.89,
15.01,
15.30mm
	Symphony 2	Angled Abutment combined with
the Symphony 2 fixture has A type
and B type, and the only
difference between the two types
is the direction when fastening.
The allowed angulations are 15°
and 25°.	Ti-6Al-
4V ELI	3.5,
4.3mm	5.5, 6.5mm
	Multi-unit Straight
Abutment	This product is intended to be
used by edentulous patients in the
Overdenture case.	Ti-6Al-
4V ELI	4.8mm	8.2, 9.2, 9.3,
10.3, 11.3,
12.3mm

6. Indication for use:

The UNIdental Symphony Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

7

7. Basis for Substantial Equivalence

7.1 Fixture

	Subject Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device
Device
Name	UNIdental
Symphony Implant
System	SuperLine	ITI Dental Implant
System	Straumann TLX
ImplantSystem	SuperLine
510(k) #	K221315	K160965	K031055	K200586	K213599
Product
Code	DZE, NHA	DZE	DZE	DZE, NHA	DZE
Manufacturer	UNIdentalCo.,Ltd	DENTIUM CO., LTD.	Straumann	Straumann USA,
LLC (on behalf of
Institut Straumann
AG)	DENTIUM CO.,
LTD.
Indications
for Use	The UNIdental
Symphony Implant
System is indicated
for use in partially or
fully edentulous
mandibles and
maxillae, in support
of single or multiple-
unit restorations
including cemented
retained, screw
retained, or
overdenture
restorations, and
terminal or
intermediate
abutment support for
fixed bridgework.
The UNIdental	SuperLine is indicated
for use in surgical and
restorative applications
for placement in the
bone of the upper or
lower jaw to provide
support for prosthetic
devices, such as
artificial teeth, in order
to restore the patient's
chewing function.
SuperLine is indicated
also for immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading.	ITI implants are
intended for surgical
placement in maxillary
and/or mandibular
arches to provide
support for prosthetic
in edentulous or
partially edentulous
patients. The ITI
Dental Implants are for
single-stage or two-
stage surgical
procedures.	Straumann TLX
Implantsare suitable
for
endostealimplantation
in the upperand lower
jaws and forthe
functional andesthetic
oral rehabilitationof
edentulous
andpartiallyedentulou
spatients. TLX
Implantscan be placed
withimmediate
function onsingle-
tooth and multi-
unitrestorations when
goodprimary stability
isachieved and
withappropriateocclus
alloading to
restorechewing
function.	SuperLine@ implants
are indicated for use
in surgical and
restorative
applications for
placement in the bone
of the upper or lower
jaw to provide
support for prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's chewing
function. SuperLine@
implants are indicated
also for immediate
loading when good
primary stability is
achieved and with
appropriate occlusal
loading.
	and two stage
surgical procedures.
It is intended for
delayed loading.			Theprosthetic
restorations
areconnected to the
implantsthroughtheco
rrespondingabutment
omponents.	implants are indicated
for delayed loading.
Implant
Design	Symphony 1Fixture
Image: Symphony 1 Fixture

Symphony
2Fixture
3.3–4.8mm | 3.6 – 7.0 mm | 3.3 – 5.37 mm | Ø3.75, 4.0, 4.5, 5.0,
5.5,and 6.5 mm | 3.6/3.6; 4.0/4.0;
4.5/4.5; 5.0/5.0;
5.0/6.0; 5.8/7.0 mm |
| | Symphony
1Fixture
7.0 – 14.0mm

510(k) summary

Page

8

510(k) summary

Page

9

| Surface
Treatment | SLA Treatment | RBM(Calcium-
Phosphate Media) | RBM(Calcium-
Phosphate Media) | Hydrophilic
SLAactive® | All implants: S.L.A.,
Al2O3 blasted and
acid etched |
|------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------|-----------------------------------------------------------|
| Implant
Surface
Finish | Aluminum oxide

99%
Sodium oxide
65%
Beta-TCP : 65%
Beta-TCP :

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 872.3640 Endosseous dental implant.

Indications for Use

K221315

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary (K221315)

1. Submitter

2. U.S Agent/Contact Person

3. Device

4. Predicate Device:

Multi-unit Abutment Plus by NOBEL BIOCARE AB (K161416) IMPLANTIUM ABUTMENTS by DENTIUM, INC. (K052823)

5. Description:

6. Indication for use:

7. Basis for Substantial Equivalence

7.1 Fixture

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