Deep Conical (DC) Implants and Accessories

K163060 · Southern Implants (Pty), Ltd. · DZE · Jun 13, 2017 · Dental

Device Facts

• Record ID: K163060
• Device Name: Deep Conical (DC) Implants and Accessories
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Deep Conical (DC) Implants and Accessories are endosseous dental implants used to support fixed or removable dental prostheses. Implants are surgically placed into the mandible or maxilla by a clinician. The system includes various implant geometries (cylindrical, tapered, and 12-degree Co-Axis) and prosthetic accessories (abutments, cover screws, cylinders). The device provides a stable foundation for tooth replacement; it integrates with bone via a moderately roughened surface. The clinician selects the appropriate implant and abutment based on the patient's anatomical needs and surgical protocol (one- or two-stage). The device benefits patients by restoring chewing function and aesthetics. The system is used in clinical settings; it does not involve digital processing or software-based decision support.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by bench testing, including fatigue testing per ISO 14801, placement torque testing, and comparative surface area/pullout strength analyses. Biocompatibility was established per ISO 10993-1.

Technological Characteristics

Implants and accessories are manufactured from Grade 4 (ASTM F67) or Grade 5 (ASTM F136) titanium. Features include deep conical connection, external threads, and microthreads. Surface is moderately roughened (except coronal region). Sterilization via Gamma radiation (ISO 11137) or moist heat (ISO 17665). Dimensions range from 6-15mm length and 3.0-5.0mm diameter. No software or electronic components.

Indications for Use

Indicated for patients requiring replacement of single or multiple missing teeth in the mandible or maxilla, including immediate placement in extraction sites or healed alveolar ridges. 3.0mm implants are restricted to maxillary lateral and mandibular incisors. Contraindicated for immediate loading in single-tooth sites <8mm or type IV (soft) bone where stability is insufficient.

Regulatory Classification

Identification

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

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• OsseoSpeed EV (K120414)
• Endosseous Implants and Accessories (K052490)
• Endosseous dental implant system (K070905)
• OT Equator (K142211)
• Endosseous dental implant system (K053478)
• Endosseous dental implant system (K070841)

Submission Summary (Full Text)

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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

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

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

Sincerely.

# 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.

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FORM FDA 3881 (8/14)

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## 510(k) Summary

#### Sponsor:

| Company Name: | Southern Implants (Pty) Ltd. |
|------------------|-------------------------------------------|
| Company Address: | 1 Albert Road<br>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<br>1 | Astra Tech AB | OsseoSpeed EV (Previously known as<br>OsseoSpeed Plus) | K120414 |
| 2 | Northern Implants | Endosseous Implants and Accessories | K052490 |
| 3 | Southern Implants,<br>Inc | Endosseous dental implant system | K070905 |
| 4 | Rhein '83 Srl | OT Equator | K142211 |
| 5 | Southern Implants,<br>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<br>(mm) | Diameters<br>(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<br>Models | Abutment<br>Connection<br>Platform | Diameters (mm) | Angulation (°) | Lengths (mm) |
|--------------------|------------------------------------|--------------------------|----------------|--------------|
| Cover Screw | Deep conical | Ø3.0, Ø3.5, Ø4.0<br>Ø5.0 | 0 | 0.25 |

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| Healing<br>Abutments | Deep conical | Ø3.0 – Ø5.0 | 0 | 2.2, 4.2, 6.2 |
|---------------------------------|------------------------------------------------|-------------|-----------|----------------|
| Overdenture<br>Abutments | Deep conical | Ø3.0 – Ø5.0 | 0 | 2, 4, 6 |
| Temporary<br>Cylinders | Deep Conical –<br>Engaging and<br>non-engaging | Ø3.0 – Ø5.0 | 0 | 10, 16 |
| Cosmetic<br>Abutments | Deep conical | Ø3.0 – Ø5.0 | 0, 12, 24 | 8.6, 8.4, 8.25 |
| Gold<br>Cylinders | Deep Conical | Ø3.0 – Ø5.0 | 0 | 13 |
| Compact<br>Conical<br>Abutments | Deep Conical –<br>Engaging and<br>non-engaging | Ø3.0 – Ø5.0 | 0 | 1.5, 3, 4, 5 |
| Passive<br>Abutments | Deep Conical –<br>Engaging and<br>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<br>Manufacturer | New device | Predicate 1<br>(Primary) | Predicate 2 |
|----------------------------|-----------------------------|--------------------------------|--------------------|
| | Southern Implants | Dentsply OsseoSpeed | Northern Implants |
| | Deep Conical (DC) | EV (Previously Plus) | Endosseous Implant |
| | Implants and<br>accessories | dental implant and<br>abutment | and accessories |

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

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#### Cylindrical Implants

| Device and Manufacturer | New device | Predicate 1<br>(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>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<br>ø5.00. | ø3.0; ø3.6; Ø4.2, ø4.8 and<br>ø5.4. |
| Body Profile | Cylindrical (Straight) | Straight |

#### Tapered Implants

| Device and Manufacturer | New device | Predicate 1 |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | | (K120414) |
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>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<br>Ø5.00. | Ø3.0; Ø3.6; Ø4.2, Ø4.8 and<br>Ø5.4. |
| Body Profile | Tapered | Straight |

#### Co-Axis Implants: Cylindrical

| Device and<br>Manufacturer | New device | Predicate 1<br>(K120414) | Predicate 2<br>(K052490) |
|----------------------------|------------|--------------------------|--------------------------|
|----------------------------|------------|--------------------------|--------------------------|

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| | Southern Implants Deep<br>Conical (DC) Implants and<br>accessories | Dentsply OsseoSpeed EV<br>dental implant and<br>abutment | Northern Implants<br>Endosseous Implant and<br>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<br>ø5.4. | ø5.0 |
| Top Angle | 12° | 0° | 12° |
| Body Profile | Cylindrical (Straight) | Straight | Tapered |

#### Co-Axis Implants: Tapered

| Device and<br>Manufacturer | New device | Predicate 1<br>(K120414) | Predicate 2<br>(K052490) |
|----------------------------|--------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|
| | Southern Implants Deep<br>Conical (DC) Implants and<br>accessories | Dentsply OsseoSpeed EV<br>dental implant and<br>abutment | Northern Implants<br>Endosseous Implant and<br>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<br>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<br>(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<br>(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>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<br>(K070905) |
|-------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Southern Implants Inc,<br>Endosseous implant and<br>accessories |
| Material | Grade 5 Titanium Alloy (ASTM<br>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<br>(DC) Implants and accessories | Endosseous implant and<br>accessories |
| | | |
| Part name | HMC<br>HMCW<br>HMCT7<br>HMCTW9 | HMC<br>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<br>(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>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 |

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| Part name | HealDesign EV | |
|-------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------------------|
| HA-DC3-2/4<br>HA-DC3-W-2/4/6<br>HA-DC4-N2<br>HA-DC4-4/6<br>HA-DC4-W-2/4/6<br>HA-DC5-2/4/6<br>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<br>(K142211) |
|-------------------------|-----------------------------------------------------------------|----------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Rhein '83 OT Equator |
| Material | Grade 5 Titanium Alloy (ASTM<br>F136) | Grade 5 Titanium Alloy (ASTM<br>F136) |
| Surface | N6 Smooth, Titanium Nitride<br>Coating | N6 Smooth, Titanium Nitride<br>Coating |
| Sterility | Sterile | Non-Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 4<br>(K142211) |
|-------------------------|-----------------------------------------------------------------|--------------------------|
| | Southern Implants Deep Conical<br>(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<br>(K120414) |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>implant and abutment |
| | Material | Grade 3 or 4 Titanium (ASTM<br>F67) |
| Sterility | Sterile | Sterile |
| Single use | Yes | Yes |

| Device and Manufacturer | New device | Predicate 1<br>(K120414) |
|-------------------------|------------|--------------------------|
|-------------------------|------------|--------------------------|

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| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>implant and abutment |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Part name | TC-DC3-1; TC-DC4-1;<br>TC-DC5-1; TC-NDC3-1; TC-NDC4-1;<br>TC-NDC5-1; TMC-1; TMC-5;<br>TMCW-1; TMCW-5; TCA-DC3;<br>TCA-DC4; TCA-DC5; | Temp Abutment EV;<br>TiDesign; Direct Abutment EV;<br>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;<br>5.6 mm | ø3.3; 4.0; 4.5; 4.7 5.0; 5.1 5.5;<br>6.0; 7.0 mm |
| Surface | Knurled and smooth | Knurled and smooth |
| Interface | Engaging and non-engaging | One position; six position; index<br>free |

#### Angled abutments

| Device and Manufacturer | New device | Predicate 1<br>(K120414) |
|-------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Dentsply OsseoSpeed EV dental<br>implant and abutment |
| Part name | TCA12-DC3; TCA12-DC4; TCA12-<br>DC5; TCA24-DC3; TCA24-DC4;<br>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<br>(K053478) |
|-------------------------|------------------------------------------------------------|-----------------------------------------------------------------|
| | | Southern Implants Deep Conical<br>(DC) Implants and accessories |
| | | |
| | | |
| Material | Ceramicor or Deringer Ney Alloy<br>6019 with Acetal sleeve | Ceramicor with acetal sleeve |
| | | |
| Sterility | Non-Sterile | Non-Sterile |
| Single use | Yes | Yes |

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

{12}------------------------------------------------

| Part name | GC-DC3; GC-DC4; GC-DC5; GC-<br>NDC3; GC-NDC4; GC-NDC5; GMC-<br>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<br>(K070841) |
|-------------------------------|-----------------------------------------------------------------|------------------------------------------------|
| | Southern Implants Deep Conical<br>(DC) Implants and accessories | NSI Inc, Endosseous implant and<br>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<br>(K053478) | |
|-------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Device and Manufacturer | Southern Implants Deep Conical<br>(DC) Implants and accessories | Southern Implants Inc,<br>Endosseous implant and<br>accessories | |
| | Material | Sleeve: acetal or delrin<br>Cylinder: grade 4 titanium (ASTM<br>F67)<br>Screw: Peek | Sleeve: acetal or delrin<br>Cylinder: grade 4 titanium (ASTM<br>F67)<br>Screw: Peek |
| | Surface | Smooth | Smooth |
| | Sterility | Non-sterile | Sterile |
| | Single use | Yes | Yes |

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

{13}------------------------------------------------

| | Southern Implants Deep Conical<br>(DC) Implants and accessories | Southern Implants Inc,<br>Endosseous implant and<br>accessories |
|-------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Part name | PA-MC-48, SB16; SB-17-TT;<br>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.