Predicate Devices

K120414, K052490, K070905, K142211, K053478, K070841

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and its accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

This device, Southern Implants Dental Implants, is designed to replace missing teeth, which directly addresses a health problem and restores function, aligning with the definition of a therapeutic device.

Diagnostic

No

Explanation: This device is a dental implant, which is a prosthetic device used to replace missing teeth. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly describes physical implants and abutments, which are hardware components, not software. The performance studies also focus on physical properties like fatigue testing and surface area analysis.

IVD (In Vitro Diagnostic)

Based on the provided information, 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 description clearly states that these are dental implants intended for surgical procedures to replace missing teeth. They are physical devices implanted into the bone.
Lack of Diagnostic Function: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status.
Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterilization, and packaging, which are typical for implantable medical devices, not IVDs.

Therefore, the Southern Implants Dental Implants are classified as a medical device, specifically an implantable device, and not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

· replacing single and multiple missing teeth in the mandible and maxilla,

· immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,

· immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

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

DZE, NHA

Device Description

The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in the following configurations.

Deep Conical Cylindrical Implants (DCC)
Lengths (mm): 11 - 15 (for Ø3.0mm), 8 – 15 (for Ø3.5mm), 6 – 15 (for Ø4.0mm), 9 – 15 (for Ø5.0mm)
Diameters (mm): Ø3.0, Ø3.5, Ø4.0, Ø5.0

Deep Conical Tapered Implants (DCT)
Lengths (mm): 9 – 15 (for Ø3.0mm), 8 – 15 (for Ø3.5mm), 6 – 15 (for Ø4.0mm), 9 – 15 (for Ø5.0mm)
Diameters (mm): Ø3.0, Ø3.5, Ø4.0, Ø5.0

Deep Conical 12º Co-Axis Cylindrical Implants (DCC-12d)
Lengths (mm): 8 – 15
Diameters (mm): Ø3.5, Ø4.0

Deep Conical 12º Co-Axis Tapered Implants (DCT-12d)
Lengths (mm): 8 – 15
Diameters (mm): Ø3.5, Ø4.0

The implants have a moderately roughened surface. The implant is non-roughened around the coronal region of the implant. The implant has an external thread and microthreads at the coronal end of the implant. The Co-Axis Implants (Cylindrical, Tapered) are only to be compatible with the straight abutments.

Abutments:
Cover Screw: Deep conical connection, Ø3.0, Ø3.5, Ø4.0, Ø5.0 mm diameters, 0° angulation, 0.25mm length.
Healing Abutments: Deep conical connection, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 2.2, 4.2, 6.2mm lengths.
Overdenture Abutments: Deep conical connection, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 2, 4, 6mm lengths.
Temporary Cylinders: Deep Conical – Engaging and non-engaging, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 10, 16mm lengths.
Cosmetic Abutments: Deep conical connection, Ø3.0 – Ø5.0 mm diameters, 0, 12, 24° angulation, 8.6, 8.4, 8.25mm lengths.
Gold Cylinders: Deep Conical connection, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 13mm length.
Compact Conical Abutments: Deep Conical – Engaging and non-engaging, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 1.5, 3, 4, 5mm lengths.
Passive Abutments: Deep Conical – Engaging and non-engaging, Ø3.0 – Ø5.0 mm diameters, 0° angulation, 11mm length.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandible and maxilla

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 provided or referenced to demonstrate substantial equivalence included detailed:

Fatigue testing in accordance with ISO 14801 to prove that the implants are sufficiently strong enough for their intended purpose. Fatigue testing was substantially equivalent to the predicate devices.
Comparative surface area, pullout strength and bone to implant contact analyses for implants less than 7mm in length was substantially equivalent to the predicate devices.
Placement torque testing results were included to show that the implants are sufficiently strong enough to withstand the torque applied to them during placement. Torque testing was substantially equivalent to the predicate devices.
The sterilization method for the subject devices is the same as the predicate. The sterilization method is Gamma radiation for the devices supplied sterile and has been validated in accordance with ISO 11137. The sterilization method is moist heat for the devices to be end user sterilized and has been validated in accordance with ISO 17665-1 and ISO 17665-2.
The packaging for the subject device is the same as the predicate. Packaging was validated in accordance with ISO 11607. Accelerated aging per ASTM-F-1980 has been applied on the final packaging followed by validating durability to peel and dye tests conditions, in order to substantiate 5 years shelf life.
The subject device is manufactured from the same material using the same manufacturing method as the applicant's own predicates (K070841, K070905, K053478, K052490), has the same intended use, and the same patient contact type and duration. The subject device is biocompatible in accordance with ISO 10993-1.

Clinical Studies: No clinical studies were conducted.

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.

K120414, K052490, K070905, K142211, K053478, K070841

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

§ 872.3640 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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

June 13, 2017

Southern Implants (Pty) Ltd % Yolanda Smith Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K163060

Trade/Device Name: Deep Conical (DC) Implants and Accessories Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 11, 2017 Received: May 11, 2017

Dear Yolanda Smith:

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.

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

1

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.

Mary S. Runner -A

Lori A. Wiggins, MPT, CLT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K163060

Device Name

Deep Conical (DC) Implants and Accessories

Indications for Use (Describe)

Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

· replacing single and multiple missing teeth in the mandible and maxilla,

· immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,

· immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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510(k) Summary

Sponsor:

Company Name:	Southern Implants (Pty) Ltd.
Company Address:	1 Albert Road
Irene, South Africa 0062
Telephone:	011 27 12 667 1046
Fax:	011 27 12 667 1029
Contact Person:	Lauranda G. Breytenbach

Summary Preparation Date:	June 12, 2017
Device Name:
Trade Name:	Deep Conical (DC) Implants and Accessories
Common/Usual Name:	Dental Implants
Classification Name:	Endosseous dental implant
Regulation Number:	21 CFR 872.3640
Product Codes:	DZE and NHA
Device Class:	Class II

Predicate Devices:

Predicate #	Manufacturer	Device Name	K Number
Primary
1	Astra Tech AB	OsseoSpeed EV (Previously known as
OsseoSpeed Plus)	K120414
2	Northern Implants	Endosseous Implants and Accessories	K052490
3	Southern Implants,
Inc	Endosseous dental implant system	K070905
4	Rhein '83 Srl	OT Equator	K142211
5	Southern Implants,
Inc	Endosseous dental implant system	K053478
6	NSI Inc	Endosseous dental implant system	K070841

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Device Description:

Implants

The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in the following configurations.

| Description | Code | Lengths
(mm) | Diameters
(mm) |
|-----------------------------------------------|---------|-----------------|-------------------|
| | | 11 - 15 | Ø3.0 |
| Deep Conical Cylindrical Implants | DCC | 8 – 15 | Ø3.5 |
| | | 6 – 15 | Ø4.0 |
| | | 9 – 15 | Ø5.0 |
| Deep Conical Tapered Implants | DCT | 9 – 15 | Ø3.0 |
| | | 8 – 15 | Ø3.5 |
| | | 6 – 15 | Ø4.0 |
| | | 9 – 15 | Ø5.0 |
| Deep Conical 12º Co-Axis Cylindrical Implants | DCC-12d | 8 – 15 | Ø3.5 |
| | | 8 – 15 | Ø4.0 |
| Deep Conical 12º Co-Axis Tapered Implants | DCT-12d | 8 – 15 | Ø3.5 |
| | | 8 – 15 | Ø4.0 |

The implants have a moderately roughened surface. The implant is non-roughened around the coronal region of the implant. The implant has an external thread and microthreads at the coronal end of the implant. The Co-Axis Implants (Cylindrical, Tapered) are only to be compatible with the straight abutments.

Abutments

The following abutments are included to be used with the Deep Conical Implants.

| Abutment
Models | Abutment
Connection
Platform | Diameters (mm) | Angulation (°) | Lengths (mm) |
|--------------------|------------------------------------|--------------------------|----------------|--------------|
| Cover Screw | Deep conical | Ø3.0, Ø3.5, Ø4.0
Ø5.0 | 0 | 0.25 |

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| Healing

Abutments	Deep conical	Ø3.0 – Ø5.0	0	2.2, 4.2, 6.2
Overdenture
Abutments	Deep conical	Ø3.0 – Ø5.0	0	2, 4, 6
Temporary
Cylinders	Deep Conical –
Engaging and
non-engaging	Ø3.0 – Ø5.0	0	10, 16
Cosmetic
Abutments	Deep conical	Ø3.0 – Ø5.0	0, 12, 24	8.6, 8.4, 8.25
Gold
Cylinders	Deep Conical	Ø3.0 – Ø5.0	0	13
Compact
Conical
Abutments	Deep Conical –
Engaging and
non-engaging	Ø3.0 – Ø5.0	0	1.5, 3, 4, 5
Passive
Abutments	Deep Conical –
Engaging and
non-engaging	Ø3.0 – Ø5.0	0	11

Indications for Use

Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

replacing single and multiple missing teeth in the mandible and maxilla,
immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
. immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

Comparison of Technical Characteristics

IMPLANTS

| Device and
Manufacturer | New device | Predicate 1
(Primary) | Predicate 2 |
|----------------------------|-----------------------------|--------------------------------|--------------------|
| | Southern Implants | Dentsply OsseoSpeed | Northern Implants |
| | Deep Conical (DC) | EV (Previously Plus) | Endosseous Implant |
| | Implants and
accessories | dental implant and
abutment | and accessories |

6

| K Number | | K120414 | K052490 | | The intended use for 3.0
Deep Conical implants is
limited to replacement
of maxillary lateral
incisors and mandibular
incisors | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------|
| Brand Name | Deep Conical Implants
and accessories | OsseoSpeed EV
(Previously OsseoSpeed
Plus) | Endosseous implants
and accessories | Intended Use | Bone anchored Dental
prosthetic | Bone anchored Dental
prosthetic | Bone anchored Dental
prosthetic |
| Product Code | DZE | DZE | DZE | Anatomical Site | Mandible and Maxilla | Mandible and Maxilla | Mandible and Maxilla |
| Regulation Number | 878.3640 | 878.3640 | 878.3640 | Material | Grade 4 titanium (ASTM
F67) | Grade 4 titanium (ASTM
F67) | Grade 4 titanium (ASTM
F67) |
| Review Panel | Dental | Dental | Dental | Implant surface | Southern Implants'
roughened surface | TiOblast surface | Southern Implants'
roughened surface |
| Regulation Name | Implant, endosseous, root form | Implant, endosseous, root form | Implant, endosseous, root form | Sterility | Sterile | Sterile | Sterile |
| Indications for Use | Southern Implants
Dental Implants are
intended for both one-
and two-stage surgical
procedures in the
following situations and
with the following
clinical protocols:
replacing single
and multiple
missing teeth in
the mandible
and maxilla,immediate
placement in
extraction sites
and in situations
with a partially
or completely
healed alveolar
ridge,immediate
loading in all
indications,
except in single
tooth situations
on implants
shorter than
8mm or in soft
bone (type IV)
| The ASTRA TECH Dental
implants are intended for
both one- and two stage
surgical procedures in
the following situations
and with the following
clinical protocols:
Replacing single or
multiple missing teeth
in the mandible and
maxilla.Immediate placement
in extraction sites and
in situations with a
partially or
completely healed
alveolar ridge.Especially indicated
for use in soft bone
applications where
implants with other
implant surface
treatments may be
less effective.Immediate loading in
all indications, except
in single tooth
situations on implants
shorter than 8 mm or
in soft bone (type IV)
where implant
stability may be
difficult to obtain and
immediate loading
may not be
appropriate.The intended use for
Osseospeed Plus 3.0 S is
limited to replacement
of maxillary lateral
incisors and mandibular
incisors. | Southern Implants
dental implants are
intended to be
implanted in the upper
and lower jaw arches to
provide support for fixed
or removable dental
prostheses in a single
tooth, partially
edentulous prostheses
or full arch prostheses.
It further adds the
option for immediate
placement, and function
on single and splinted
multiple unit
restorations when good
primary stability is
achieved and with
appropriate occlusal
loading, to restore
chewing function. | Connection system | Deep Conical | Deep Conical | N/A |
| Flutes | 2 | 2 | N/A | | | | |
| Body type | Threaded with
microthreads at the
coronal end of the
implant | Threaded with
microthreads at the
coronal end of the
implant | Threaded | | | | |

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Cylindrical Implants

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
| Part name | DCC | OsseoSpeed EV |
| Body lengths (mm) | 6.1; 8; 9; 11; 13; 15 | 6; 8; 9; 11; 13; 15; 17 |
| Diameters (mm) | ø3.02; ø3.52; ø4.00 and
ø5.00. | ø3.0; ø3.6; Ø4.2, ø4.8 and
ø5.4. |
| Body Profile | Cylindrical (Straight) | Straight |

Tapered Implants

Device and Manufacturer	New device	Predicate 1
		(K120414)
	Southern Implants Deep Conical
(DC) Implants and accessories	Dentsply OsseoSpeed EV dental
implant and abutment
Part name	DCT	OsseoSpeed EV
Body lengths (mm)	6.1; 8; 9; 11; 13; 15	6; 8; 9; 11; 13; 15; 17
Diameters (mm)	Ø3.02; Ø3.52; Ø4.00 and
Ø5.00.	Ø3.0; Ø3.6; Ø4.2, Ø4.8 and
Ø5.4.
Body Profile	Tapered	Straight

Co-Axis Implants: Cylindrical

----------------------------	------------	--------------------------	--------------------------

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| | Southern Implants Deep
Conical (DC) Implants and
accessories | Dentsply OsseoSpeed EV
dental implant and
abutment | Northern Implants
Endosseous Implant and
accessories |
|-------------------|--------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| Part name | DCC-12d | OsseoSpeed EV | BAT12d and BBBT12d |
| Body lengths (mm) | 8; 9; 11; 13; 15 | 6; 8; 9; 11; 13; 15; 17 | 10; 11.5; 13; 15; 18 mm |
| Diameters (mm) | ø3.52 and ø4.00 | ø3.0; ø3.6; ø4.2, ø4.8 and
ø5.4. | ø5.0 |
| Top Angle | 12° | 0° | 12° |
| Body Profile | Cylindrical (Straight) | Straight | Tapered |

Co-Axis Implants: Tapered

| Device and
Manufacturer | New device | Predicate 1
(K120414) | Predicate 2
(K052490) |
|----------------------------|--------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| | Southern Implants Deep
Conical (DC) Implants and
accessories | Dentsply OsseoSpeed EV
dental implant and
abutment | Northern Implants
Endosseous Implant and
accessories |
| Part name | DCT-12d | OsseoSpeed EV | BAT12d and BBBT12d |
| Body lengths (mm) | 8; 9; 11; 13; 15 | 6; 8; 9; 11; 13; 15; 17 | 10; 11.5; 13; 15; 18 mm |
| Diameters (mm) | ø3.52 and ø4.00 | ø3.0; ø3.6; ø4.2, ø4.8 and
ø5.4. | ø5.0 and ø6.0 |
| Top Angle | 12° | 0° | 12° |
| Body Profile | Tapered | Straight | Tapered |

ACCESSORIES: COVER SCREWS

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------|--------------------------------------------------------------|----------------------------------------------------|
| | Southern Implants Deep Conical (DC) Implants and accessories | Dentsply OsseoSpeed EV dental implant and abutment |
| Material | Grade 4 commercially pure Titanium (ASTM F67) | Titanium |
| Surface | Smooth, machined (N6) | Smooth, machined (N6) |
| Sterility | Sterile | Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
| Part name | CS-DC3/4/5 | 25280/1/2/3 |

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ACCESSORIES: HEALING ABUTMENTS

Healing Caps

| Device and Manufacturer | New device | Predicate 3
(K070905) |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Southern Implants Inc,
Endosseous implant and
accessories |
| Material | Grade 5 Titanium Alloy (ASTM
F136) | Stainless Steel 303 |
| Surface | Smooth, N6 | Smooth, N6 |
| Sterility | Sterile | Sterile |
| Single use | Yes | Yes |

Device and Manufacturer	New device	Predicate 3
		(K070905)
	Southern Implants Deep Conical
(DC) Implants and accessories	Endosseous implant and
accessories

Part name	HMC
HMCW
HMCT7
HMCTW9	HMC
HMCT7
Abutment length	4.60; 6.20 mm	4.60; 6.20 mm
Platform diameter	ø4.8; ø6.0; ø7.0; and ø9.0 mm	ø4.8 and ø7.0

Healing abutments

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
| Material | Grade 3 or 4 Titanium (ASTM F67) | Titanium |
| Surface | Smooth, N6 | Smooth, N6 |
| Sterility | Sterile | Sterile |

Device and Manufacturer	New device	Predicate 1
		(K120414)
	Southern Implants Deep Conical	Dentsply OsseoSpeed EV dental
	(DC) Implants and accessories	implant and abutment

10

Part name	HealDesign EV
HA-DC3-2/4
HA-DC3-W-2/4/6
HA-DC4-N2
HA-DC4-4/6
HA-DC4-W-2/4/6
HA-DC5-2/4/6
HA-DC5-W-2/4/6
Abutment length	2.2; 4.2; 6.2 mm	2.5; 3.5; 4.5; 6.5 mm
Platform Diameter	ø3.5; ø4.0; ø4.5; ø5.5; ø6.5 mm	ø3.5; ø4.0; ø5.0; ø6.5; ø7.5 mm

ACCESSORIES: OVERDENTURE ABUTMENTS

| Device and Manufacturer | New device | Predicate 4
(K142211) |
|-------------------------|-----------------------------------------------------------------|----------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Rhein '83 OT Equator |
| Material | Grade 5 Titanium Alloy (ASTM
F136) | Grade 5 Titanium Alloy (ASTM
F136) |
| Surface | N6 Smooth, Titanium Nitride
Coating | N6 Smooth, Titanium Nitride
Coating |
| Sterility | Sterile | Non-Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 4
(K142211) |
|-------------------------|-----------------------------------------------------------------|--------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Rhein '83 OT Equator |
| Part name | EQ-DC | OT Equator Abutment |
| Head diameter | ø2.5 mm | ø2.5 mm |
| Head height | 1.4mm | 2.0 mm |
| Collar heights | 2; 3; 4; 5 mm | 1 - 7 mm |

ACCESSORIES: TITANIUM ABUTMENTS

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
| | Material | Grade 3 or 4 Titanium (ASTM
F67) |
| Sterility | Sterile | Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 1
(K120414) |

-------------------------	------------	--------------------------

11

| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Part name | TC-DC3-1; TC-DC4-1;
TC-DC5-1; TC-NDC3-1; TC-NDC4-1;
TC-NDC5-1; TMC-1; TMC-5;
TMCW-1; TMCW-5; TCA-DC3;
TCA-DC4; TCA-DC5; | Temp Abutment EV;
TiDesign; Direct Abutment EV;
Titanium base; Uni Abutment |
| Collar height | 1; 1.5; 1.875; 5 mm | 1 - 5 mm |
| Restorative platform diameter | ø3.4; 4.1; 4.2; 4.4; 4.6; 5.0; 5.2;
5.6 mm | ø3.3; 4.0; 4.5; 4.7 5.0; 5.1 5.5;
6.0; 7.0 mm |
| Surface | Knurled and smooth | Knurled and smooth |
| Interface | Engaging and non-engaging | One position; six position; index
free |

Angled abutments

| Device and Manufacturer | New device | Predicate 1
(K120414) |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Dentsply OsseoSpeed EV dental
implant and abutment |
| Part name | TCA12-DC3; TCA12-DC4; TCA12-
DC5; TCA24-DC3; TCA24-DC4;
TCA24-DC5 | TiDesign EV |
| Collar height | 1.5mm | 1.5 mm |
| Restorative platform diameter | ø4.20; 4.60 and 5.60 mm | ø4.0; 4.5; 5.5; 7.0 mm |
| Surface | Smooth | Smooth |
| Angulation | 12 ° and 24 ° | 15 ° and 20 ° |

ACCESSORIES: GOLD CYLINDERS

| Device and Manufacturer | New device | Predicate 5
(K053478) |
|-------------------------|------------------------------------------------------------|-----------------------------------------------------------------|
| | | Southern Implants Deep Conical
(DC) Implants and accessories |
| | | |
| | | |
| Material | Ceramicor or Deringer Ney Alloy
6019 with Acetal sleeve | Ceramicor with acetal sleeve |
| | | |
| Sterility | Non-Sterile | Non-Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 4
(K053478) |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | Southern Implants Inc,
Endosseous implant and
accessories |

12

| Part name | GC-DC3; GC-DC4; GC-DC5; GC-
NDC3; GC-NDC4; GC-NDC5; GMC-
1; GMCW-1 | GC-EX-34; GMC-1 |
|-------------------------------|--------------------------------------------------------------------------|---------------------------|
| Collar length | 1.0 mm | 1.0 mm |
| Restorative platform diameter | ø3.4; 3.82; 4.1; 4.5; 4.55 mm | ø3.82; 4.0 mm |
| Surface | Knurled | Knurled |
| Interface | Engaging and non-engaging | Engaging and non-engaging |

ACCESSORIES: COMPACT CONICAL ABUTMENTS

Device and Manufacturer	New device	Predicate 6 (K070841)
	Southern Implants Deep Conical (DC) Implants and accessories	NSI Inc, Endosseous implant and accessories
Material	Grade 5 Titanium Alloy (ASTM F136)	Grade 5 Titanium Alloy (ASTM F136)
Surface	Smooth	Smooth
Sterility	Sterile	Sterile
Single use	Yes	Yes

| Device and Manufacturer | New device | Predicate 6
(K070841) |
|-------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| | Southern Implants Deep Conical
(DC) Implants and accessories | NSI Inc, Endosseous implant and
accessories |
| Part name | MC-DC3; MC-DC4; MC-DC5 | AMCZ1 |
| Abutment length | 1.5; 3.0; 4.0 and 5.0 mm | 1.5 mm |
| Restorative platform diameter | ø4.80 and 6.0 mm | ø4.05 mm |

ACCESSORIES: PASSIVE ABUTMENTS

| Device and Manufacturer | New device | Predicate 5
(K053478) | |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Device and Manufacturer | Southern Implants Deep Conical
(DC) Implants and accessories | Southern Implants Inc,
Endosseous implant and
accessories | |
| | Material | Sleeve: acetal or delrin
Cylinder: grade 4 titanium (ASTM
F67)
Screw: Peek | Sleeve: acetal or delrin
Cylinder: grade 4 titanium (ASTM
F67)
Screw: Peek |
| | Surface | Smooth | Smooth |
| | Sterility | Non-sterile | Sterile |
| | Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 5
(K053478) |
|-------------------------|------------|--------------------------|
| | | |

13

| | Southern Implants Deep Conical
(DC) Implants and accessories | Southern Implants Inc,
Endosseous implant and
accessories |
|-------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Part name | PA-MC-48, SB16; SB-17-TT;
SBV16; SBV-17-TT | PA-MC-48, SB16; SB-17-TT |
| Collar Height | 1.0; 2.7 mm | 1.6; 2.7 mm |
| Restorative platform diameter | ø3.4; 4.1; 4.5; 4.8; 6.0 | ø4.8; 4.1; 4.3mm |

Nonclinical Testing and Performance Testing

Non-clinical testing data provided or referenced to demonstrate substantial equivalence included detailed:

. Fatigue testing in accordance with ISO 14801 to prove that the implants are sufficiently strong enough for their intended purpose. Fatigue testing was substantially equivalent to the predicate devices.
. Comparative surface area, pullout strength and bone to implant contact analyses for implants less than 7mm in length was substantially equivalent to the predicate devices.
Placement torque testing results were included to show that the implants are sufficiently ● strong enough to withstand the torque applied to them during placement. Torque testing was substantially equivalent to the predicate devices.
. The sterilization method for the subject devices is the same as the predicate. The sterilization method is Gamma radiation for the devices supplied sterile and has been validated in accordance with ISO 11137. The sterilization method is moist heat for the devices to be end user sterilized and has been validated in accordance with ISO 17665-1 and ISO 17665-2.
. The packaging for the subject device is the same as the predicate. Packaging was validated in accordance with ISO 11607. Accelerated aging per ASTM-F-1980 has been applied on the final packaging followed by validating durability to peel and dye tests conditions, in order to substantiate 5 years shelf life.
. The subject device is manufactured from the same material using the same manufacturing method as the applicant's own predicates (K070841, K070905, K053478, K052490), has the same intended use, and the same patient contact type and duration. The subject device is biocompatible in accordance with ISO 10993-1.

Clinical Studies

No clinical studies were conducted.

Final Conclusion

Southern Implants Deep Conical Implant range are substantially equivalent to the predicate devices in:

Indication for use;
Intended use;
Anatomical site;
Material;
Sterility;
Connection interface;
Body type and flutes;
Lengths and diameters

14

The indications for use are considered substantially equivalent to the primary predicate. The only difference is the subject device is less restrictive and does not include an indication for soft bone applications based on implant surface treatment. The only design differences are the roughened surfaces and the geometry of the implants. Tapered and co-axis implants are substantially equivalent to other devices already on the market. These differences are therefore not considered to be significant.

The Southern Implants Deep Conical Accessories which includes abutments and cover screws are substantially equivalent to the predicate devices in intended use as support accessories for prosthetic restorations. Technological characteristics are substantially equivalent to the predicates.

Based on the information contained in this submission Southern Implants thus concludes that the device is substantially equivalent to the predicate devices.