(224 days)
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
The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in Cylindrical, Tapered, Deep Conical 12º Co-Axis Cylindrical, and Deep Conical 12º Co-Axis Tapered configurations with various lengths and diameters. The implants have a moderately roughened surface, are non-roughened around the coronal region, and have an external thread and microthreads at the coronal end. The Co-Axis Implants are compatible only with straight abutments. The submission also includes various abutments (Cover Screw, Healing Abutments, Overdenture Abutments, Temporary Cylinders, Cosmetic Abutments, Gold Cylinders, Compact Conical Abutments, Passive Abutments, Titanium Abutments, Angled abutments) designed for use with the Deep Conical Implants.
The provided text is a 510(k) Summary for a medical device (Deep Conical (DC) Implants and Accessories) and does not describe an AI/ML powered device. Therefore, it does not include acceptance criteria, performance studies, or details regarding AI model development such as training/test set sizes, ground truth establishment, or expert involvement.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.
Here's an overview of the non-clinical testing performed, but please note that this is not a performance study for an AI/ML device:
Non-clinical Testing and Performance Testing (for a dental implant device, not AI/ML):
- Fatigue testing: In accordance with ISO 14801, to prove sufficient strength. Reported as substantially equivalent to predicate devices.
- Comparative surface area, pullout strength and bone to implant contact analyses: For implants less than 7mm in length. Reported as substantially equivalent to predicate devices.
- Placement torque testing: To show sufficient strength to withstand placement torque. Reported as substantially equivalent to predicate devices.
- Sterilization method validation: Gamma radiation (for sterile devices) validated per ISO 11137; moist heat (for end-user sterilized devices) validated per ISO 17665-1 and ISO 17665-2.
- Packaging validation: In accordance with ISO 11607, with accelerated aging per ASTM-F-1980 to substantiate 5 years shelf life.
- Biocompatibility: The device is manufactured from the same material using the same method as the applicant's predicates, has the same intended use, and patient contact type and duration. It is reported as biocompatible in accordance with ISO 10993-1.
Absence of AI/ML Specific Information:
The document explicitly states: "No clinical studies were conducted." This further confirms the lack of any study that would typically be associated with evaluating the performance of an AI/ML device.
Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document as it pertains to a different type of medical device (dental implants) and its regulatory pathway (510(k) for substantial equivalence).
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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 RoadIrene, 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 |
|---|---|---|---|
| Primary1 | Astra Tech AB | OsseoSpeed EV (Previously known asOsseoSpeed 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.
| AbutmentModels | AbutmentConnectionPlatform | Diameters (mm) | Angulation (°) | Lengths (mm) |
|---|---|---|---|---|
| Cover Screw | Deep conical | Ø3.0, Ø3.5, Ø4.0Ø5.0 | 0 | 0.25 |
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| HealingAbutments | Deep conical | Ø3.0 – Ø5.0 | 0 | 2.2, 4.2, 6.2 |
|---|---|---|---|---|
| OverdentureAbutments | Deep conical | Ø3.0 – Ø5.0 | 0 | 2, 4, 6 |
| TemporaryCylinders | Deep Conical –Engaging andnon-engaging | Ø3.0 – Ø5.0 | 0 | 10, 16 |
| CosmeticAbutments | Deep conical | Ø3.0 – Ø5.0 | 0, 12, 24 | 8.6, 8.4, 8.25 |
| GoldCylinders | Deep Conical | Ø3.0 – Ø5.0 | 0 | 13 |
| CompactConicalAbutments | Deep Conical –Engaging andnon-engaging | Ø3.0 – Ø5.0 | 0 | 1.5, 3, 4, 5 |
| PassiveAbutments | Deep Conical –Engaging andnon-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 andManufacturer | New device | Predicate 1(Primary) | Predicate 2 |
|---|---|---|---|
| Southern Implants | Dentsply OsseoSpeed | Northern Implants | |
| Deep Conical (DC) | EV (Previously Plus) | Endosseous Implant | |
| Implants andaccessories | dental implant andabutment | and accessories |
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| K Number | K120414 | K052490 | The intended use for 3.0Deep Conical implants islimited to replacementof maxillary lateralincisors and mandibularincisors | ||||
|---|---|---|---|---|---|---|---|
| Brand Name | Deep Conical Implantsand accessories | OsseoSpeed EV(Previously OsseoSpeedPlus) | Endosseous implantsand accessories | Intended Use | Bone anchored Dentalprosthetic | Bone anchored Dentalprosthetic | Bone anchored Dentalprosthetic |
| 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 (ASTMF67) | Grade 4 titanium (ASTMF67) | Grade 4 titanium (ASTMF67) |
| 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 ImplantsDental Implants areintended for both one-and two-stage surgicalprocedures in thefollowing situations andwith the followingclinical protocols:replacing singleand multiplemissing teeth inthe mandibleand maxilla,immediateplacement inextraction sitesand in situationswith a partiallyor completelyhealed alveolarridge,immediateloading in allindications,except in singletooth situationson implantsshorter than8mm or in softbone (type IV) | The ASTRA TECH Dentalimplants are intended forboth one- and two stagesurgical procedures inthe following situationsand with the followingclinical protocols:Replacing single ormultiple missing teethin the mandible andmaxilla.Immediate placementin extraction sites andin situations with apartially orcompletely healedalveolar ridge.Especially indicatedfor use in soft boneapplications whereimplants with otherimplant surfacetreatments may beless effective.Immediate loading inall indications, exceptin single toothsituations on implantsshorter than 8 mm orin soft bone (type IV)where implantstability may bedifficult to obtain andimmediate loadingmay not beappropriate.The intended use forOsseospeed Plus 3.0 S islimited to replacementof maxillary lateralincisors and mandibularincisors. | Southern Implantsdental implants areintended to beimplanted in the upperand lower jaw arches toprovide support for fixedor removable dentalprostheses in a singletooth, partiallyedentulous prosthesesor full arch prostheses.It further adds theoption for immediateplacement, and functionon single and splintedmultiple unitrestorations when goodprimary stability isachieved and withappropriate occlusalloading, to restorechewing function. | Connection system | Deep Conical | Deep Conical | N/A |
| Flutes | 2 | 2 | N/A | ||||
| Body type | Threaded withmicrothreads at thecoronal end of theimplant | Threaded withmicrothreads at thecoronal end of theimplant | 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 dentalimplant 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 andø5.00. | ø3.0; ø3.6; Ø4.2, ø4.8 andø5.4. |
| 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 dentalimplant 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 andØ5.00. | Ø3.0; Ø3.6; Ø4.2, Ø4.8 andØ5.4. |
| Body Profile | Tapered | Straight |
Co-Axis Implants: Cylindrical
| Device andManufacturer | New device | Predicate 1(K120414) | Predicate 2(K052490) |
|---|---|---|---|
| ---------------------------- | ------------ | -------------------------- | -------------------------- |
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| Southern Implants DeepConical (DC) Implants andaccessories | Dentsply OsseoSpeed EVdental implant andabutment | Northern ImplantsEndosseous Implant andaccessories | |
|---|---|---|---|
| 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 andø5.4. | ø5.0 |
| Top Angle | 12° | 0° | 12° |
| Body Profile | Cylindrical (Straight) | Straight | Tapered |
Co-Axis Implants: Tapered
| Device andManufacturer | New device | Predicate 1(K120414) | Predicate 2(K052490) |
|---|---|---|---|
| Southern Implants DeepConical (DC) Implants andaccessories | Dentsply OsseoSpeed EVdental implant andabutment | Northern ImplantsEndosseous Implant andaccessories | |
| 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 andø5.4. | 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 dentalimplant 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 andaccessories | |
| Material | Grade 5 Titanium Alloy (ASTMF136) | 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 andaccessories | |
| Part name | HMCHMCWHMCT7HMCTW9 | HMCHMCT7 |
| 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 dentalimplant 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-DC3-2/4HA-DC3-W-2/4/6HA-DC4-N2HA-DC4-4/6HA-DC4-W-2/4/6HA-DC5-2/4/6HA-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 (ASTMF136) | Grade 5 Titanium Alloy (ASTMF136) |
| Surface | N6 Smooth, Titanium NitrideCoating | N6 Smooth, Titanium NitrideCoating |
| 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 dentalimplant and abutment | |
| Material | Grade 3 or 4 Titanium (ASTMF67) | |
| Sterility | Sterile | Sterile |
| Single use | Yes | Yes |
| Device and Manufacturer | New device | Predicate 1(K120414) |
|---|---|---|
| ------------------------- | ------------ | -------------------------- |
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| Southern Implants Deep Conical(DC) Implants and accessories | Dentsply OsseoSpeed EV dentalimplant 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; indexfree |
Angled abutments
| Device and Manufacturer | New device | Predicate 1(K120414) |
|---|---|---|
| Southern Implants Deep Conical(DC) Implants and accessories | Dentsply OsseoSpeed EV dentalimplant 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 Alloy6019 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 andaccessories |
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| 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 andaccessories | |
| 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 andaccessories | |
| Material | Sleeve: acetal or delrinCylinder: grade 4 titanium (ASTMF67)Screw: Peek | Sleeve: acetal or delrinCylinder: grade 4 titanium (ASTMF67)Screw: Peek | |
| Surface | Smooth | Smooth | |
| Sterility | Non-sterile | Sterile | |
| Single use | Yes | Yes |
| Device and Manufacturer | New device | Predicate 5(K053478) |
|---|---|---|
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| Southern Implants Deep Conical(DC) Implants and accessories | Southern Implants Inc,Endosseous implant andaccessories | |
|---|---|---|
| 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
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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.
§ 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.