Surcam Dental Implant System
Device Facts
| Record ID | K242217 |
|---|---|
| Device Name | Surcam Dental Implant System |
| Applicant | Surcam Medical Devices and Developments, Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jan 29, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments. Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.
Device Story
Endosseous dental implant system comprising implants, abutments, cover screws, and healing caps; available in conical and internal hex connections. Implants placed in jaw bone to support prosthetic teeth. System supports immediate loading protocols. Used in dental clinics by trained professionals. Output is a stable foundation for dental prosthetics; aids in restoring patient chewing function. Material: Ti-6AL-4V ELI. System includes various diameters and lengths to accommodate anatomical requirements.
Clinical Evidence
Bench testing only. Dynamic fatigue testing per ISO 14801; surface cleanliness analysis; sterilization validation per ISO 11137-1/2 and ISO 17665-1/2; endotoxin testing per USP 161; shelf life and package integrity testing per ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, and ISO 11607-1. Non-clinical MRI safety assessment performed using scientific rationale and published literature.
Technological Characteristics
Materials: ASTM F136 Ti-6AL-4V ELI. Connections: Internal hex and conical. Surface treatment: Alumina blasted and acid etched. Sterilization: Implants (ISO 11137-1/2), Abutments (ISO 17665-1/2). Dimensions: Various diameters (3.3mm–6.0mm) and lengths (8mm–18mm).
Indications for Use
Indicated for surgical and restorative applications in the upper or lower jaw to support prosthetic devices (artificial teeth) for patients requiring restoration of chewing function. Includes immediate loading when primary stability and occlusal loading are appropriate. C Type 3.3mm implants restricted to straight abutments; temporary cylinders restricted to splinted restorations.
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
- Surgikor Dental Implant System (K182615)
Reference Devices
- Straumann (K191123)
- Cortex Dental Implants (K090709)
- Cortex Dental Implants (K163385)
- AB Dental Implants (K132125)
- OsseOne (K182293)
- Dentsply Sirona (K163350)
- Osstem (K161604)
Related Devices
- K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
- K240837 — TOV Dental Implant System · Rdj Tov Implant, Ltd. · Aug 15, 2024
- K152555 — Dental Implant System · Ariabio International, Inc. · Feb 11, 2016
- K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus · Jdentalcare Srl · Aug 16, 2024
- K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012
Submission Summary (Full Text)
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January 29, 2025
Surcam Medical Devices and Developments Ltd % Angela Blackwell senior consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172
Re: K242217
Trade/Device Name: Surcam Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 6, 2025 Received: January 7, 2025
Dear Angela Blackwell:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K242217
Device Name Surcam Dental Implant System
#### Indications for Use (Describe)
The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.
Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 510k Summary K242217 January 28, 2025 Surcam Dental Implant System
#### Name and address of Submitter: Surcam
Northern Industrial Zone P.O.B. 12084 Nahariya 2201202 Israel Contact Person: Shay Ben Shabat Phone Number: +972 49523511 Name of device: Surcam Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA
#### Submission Contact:
Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com
Device Description: The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.
The Surcam Dental Implant System includes:
Conical Connection Devices
Conical connection implants and abutments should be matched by platform size of either NP or RP.
LSA Implants 3.5, 4.3, 5.0mm diameter in lengths of 8,10,11.5,13 and 15mm (no 15 in 5.0)
Cover Screw NP 3.0 x 4.0mm
Cover Screw RP 6.0 x 3.5mm
Healing Cap NP 3.6 x 2.95, 4.95, 6.95mm height above platform, total heights 8.3, 10.3, 12.3mm Healing Cap NP 5.0 x 2.95, 4.95, 6.95mm height above platform, total heights 8.3, 10.3, 12.3mm Healing Cap RP 3.6 x 2.95, 4.95, 6.95mm height above platform, total heights 8.3, 10.3, 12.3mm
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Healing Cap RP 5.0 x 2.8, 4.8, 6.8mm height above platform, total heights 8.3, 10.3, 12.3mm
Angled Abutment 15° GH 1.5mm NP 4.2 x 10.3mm total height, 7.95mm height above platform Angled Abutment 15° G H3.0mm NP 4.2 x 11.8mm total height, 9.45mm height above platform Angled Abutment 15° GH 1.5mm RP 5.0 x 10.3mm total height, 7.3mm height above platform Angled Abutment 15° GH 2.9mm RP 5.0 x 11.8mm total height, 9.3mm height above platform
Straight Titanium Anatomic GH 1.48 mm Abutment 3.0x 10.3mm total height, 7.8mm height above platform NP Straight Titanium Anatomic GH 1.4mm Abutment 5.0 x 10.3mm total height above platform RP Straight Titanium Anatomic GH 2.9mm Abutment 3.0 x 11.8mm total height above platform NP Straight Titanium Anatomic GH 2.9mm Abutment 5.0 x 11.8mm total height above platform RP
Straight Multi-Unit NP GH 1.35, 2.35, 3.35, 4.35, 5.35mm 3.0 x 9, 10, 11, 12, 13mm total height, 2.15mm height above platform Straight Multi-Unit RP GH 1.3, 2.3, 3.3, 4.3, 5.3mm 4.3 x 9, 10, 11, 12, 13mm total height, 2.15mm height above platform
Healing Cap for multi-unit 5.0 x5.0mm Short sleeve for multi-unit 5.0 x 4.41mm Titanium sleeve for multi-unit 6.0 x 12mm Screw for multi-unit sleeve Longer screw for multi-unit sleeve Screw for conical multi-unit and abutments NP Screw for conical multi-unit RP Conical abutment screw RP Conical abutment screw NP
Internal Hex Connection Devices
Internal hex implants and abutments only come in one platform so all abutments will fit all implants. Temporary abutments are for use less than 180 days. C & S Type 3.3mm implants are for use with straight abutments only.
S-Type Implant 3.3, 3.75, 4.2, 5.0, 6.0mm diameter in lengths of 8, 10, 11.5, 13, 16 (not in 3.3 or 6.0), 18 (3.75 and 4.2 only) mm
C-Type Implant 3.3, 3.75, 4.2, 5.0, 6.0mm diameter in lengths of 8, 10, 11.5, 13, 16 (not in 5.0 or 6.0), 18 (3.75 only) mm
Cover Screw internal hex
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Concave healing cap 5.5 x 7.95, 8.95, 9.95, 10.95mm total height 2.75, 3.75, 4.75, 5.75 height above platform For 5.0mm diameter implants Healing cap slim 4.5 x 8.2, 9.2, 10.2, 12.2mm total height 3.17, 4.17, 5.17, 6.17, 7.17mm height above platform For 4.2mm diameter implants Healing cap 5.5 x 7.5, 8.1, 9.05, 11.05mm total height 2.3.4.5.6mm height above platform For 5.0mm diameter implants Healing cap slim 4.5 x 9.05, 10.05mm total height 4.5mm height above platform For 4.2mm diameter implants Healing cap extra slim 3.5 x 6.9, 7.9, 8.9mm total height above platform For 3.3 and 3.75mm diameter implants Healing cap wide 6.3 x 8, 9, 9.6mm total height 3,4,5mm height above platform For 6.0mm diameter implants
Straight multi-unit 5.0 x 8.5, 9.5, 10.5, 11.5, 12.5mm total height GH 1.2.2.2.3.2.4.2.5.2mm 2.2mm height above platform
Straight multi-unit 5.0 x 9. 10. 10.7. 12.7mm total height GH 1.17.2.17.3.4.5mm 2.2mm height above platform
Angled multi-unit 18° 3.75mm diameter GH .55, 1.35, 2.62mm 5.7, 6.5, 7.8mm total height
18° overdenture abutment 3.75mm diameter GH .54. 1.3. 2.35. 3.57mm 5.7. 6.5. 7.6. 8.85mm total height
Healing Cap for multi-unit 5.0 x 5.0mm Short sleeve for multi-unit 5.0 x 4.1mm Titanium sleeve for multi-unit 6.0 x 12mm Screw for multi-unit sleeve Longer screw for multi-unit sleeve Internal hex abutment screw Internal hex multi-unit screw
Straight Curve Concave Abutments 3.75mm diameter GH 1,2,3,4mm 11, 12, 13, 14mm total height Straight anatomic abutment 3.75mm diameter GH 1,2,3.3.7mm 11, 12, 13, 14mm total height Straight wide anatomic abutment 4.5mm diameter GH 1,2,2.7mm 11, 12, 13mm total height Straight shoulder abutment 3.75mm diameter GH 1.15,2.15,3 mm 11, 12, 13mm total height
15° Concave Curve Abutment GH 1.05.2.3,4mm 11, 12, 13, 14mm total height 25° Concave Curve Abutment GH 1,2,3,4mm 11, 12, 13, 14mm total height
15° Anatomic Abutment 3.75mm diameter GH 1,1.9,3,3.7mm 11, 12, 12.5, 13.7mm total height
25° Anatomic Abutment 3.75mm diameter GH 1,2,3,4mm 11, 12, 12.8, 13.5mm total height
15° Wide Anatomic Abutment 4.5mm diameter GH 1.25.2mm 11, 12mm total height
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15° Smooth abutment 3.75mm diameter Total height of 9, 11, 13.5mm gingival height 1,1,1.5mm Post height 5.93, 7, 8mm
15° Smooth thin abutment 3.75mm diameter total height 11mm gingival height 0.5mm Post height 9mm
15° Smooth wide abutment 4.5mm diameter total height 1.5mm Post height 1.5mm Post height 7mm
25° Smooth abutment 3.75mm diameter Total height 9.5. 11. 13.5mm Gingival height 1.5, 1, 2.8mm Post height 8, 8, 9mm
Indications for Use: The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.
Temporary cylinders must be in a splinted restoration only and are not for single crown restorations.
Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Surface cleanliness analysis of the implants was done and all tests were passed. Sterilization according to ISO 11137-1 and 11137-2 was conducted on the implants. Abutment steam sterilization was done according to ISO 17665-1 and -2. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted. Shelf life and package integrity testing were conducted according to ASTM F1980 ASTM F1929, ASTM 2338, ASTM D3078 and ISO 11607-1. The shelf life is 5 years.
## MR Environment Condition
Non-clinical worst-case MRI review was performed to evaluate the metallic Surcam Dental Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.
Predicate Device: Surgikor Dental Implant System K182615 Reference Devices: Straumann K191123, Cortex Dental Implants K090709 and K163385 AB Dental Implants K132125, OsseOne K182293, Dentsply Sirona K163350 and Osstem K161604
## Substantial Equivalence:
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The Surcam Dental Implant System is substantially equivalent to Surgikor Dental Implants in indications for use, materials, design, and fatigue performance. Slight differences in implant and angled abutment design between the subject devices and the predicate devices were addressed by showing both had adequate fatigue performance. Larger size implants and abutments as well as some abutment designs needed a reference device. The primary predicate supports the wider diameter subject device (i.e., 6mm). The restriction included in the Indications for use for the primary predicate device pertains to the 7mm diameter implant body only and is not applicable to the subject device implant bodies. The Cortex reference device is used for demonstrating equivalence to some designs and sizes which are not present in the later Cortex predicate submission. The OsseOne, Dentsply Sirona and AB Dental Implants reference devices are used to demonstrate equivalence in abutments designs and heights which are not in the predicate device submission.
| Company &<br>Device Name | Surcam Dental<br>Implant System | Surgikor<br>Dental<br>Implant<br>System<br>K182615 | Cortex Dental<br>Implants<br>K090709 and<br>K163385 | Osstem K161604 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | . The Surcam<br>Dental Implant<br>System is indicated<br>for use in surgical<br>and restorative<br>applications for<br>placement in the<br>bone of the upper<br>or lower jaw to<br>provide support for<br>prosthetic devices,<br>such as artificial<br>teeth, in order to<br>restore the<br>patient's chewing<br>function. The<br>Dental Implant<br>System is indicated<br>also for immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate<br>occlusal loading.<br>The C Type and S<br>Type 3.3mm<br>diameter implants<br>are indicated for | Surgikor's<br>Dental<br>Implant<br>System is<br>indicated<br>for use in<br>surgical<br>and<br>restorativ<br>e<br>applicatio<br>ns for<br>placement<br>in the<br>bone of<br>the upper<br>or lower<br>jaw to<br>provide<br>support<br>for<br>prosthetic<br>devices,<br>such as<br>artificial<br>teeth, in<br>order to<br>restore<br>the | Cortex Dental<br>Implant System<br>is intended for<br>immediate<br>loading when<br>good primary<br>stability is<br>achieved and<br>with<br>appropriate<br>occlusal loading<br>for use in<br>surgical (single-<br>stage or two-<br>stage<br>procedures) and<br>restorative<br>applications for<br>placement in<br>the bone of the<br>upper or lower<br>jaw to provide<br>support for<br>prosthetic<br>device such as<br>artificial teeth<br>and to restore<br>the patient's<br>chewing | The Osstem<br>Implant is<br>indicated for use<br>in partially or<br>fully edentulous<br>mandibles and<br>maxillae, in<br>support of single<br>or<br>multiple-unit<br>restorations<br>including;<br>cemented<br>retained, screw<br>retained, or<br>overdenture<br>restorations, and<br>final or<br>temporary<br>abutment<br>support for fixed<br>bridgework. It is<br>intended for<br>delayed loading.<br>Ultra Wide<br>Fixture System is<br>intended to be<br>used in the molar<br>region. |
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| | | use with only<br>straight abutments.<br>Temporary<br>cylinders must be<br>in a splinted<br>restoration only<br>and are not for<br>single crown<br>restorations. | patient's<br>chewing<br>function.<br>The<br>Dental<br>Implant<br>System is<br>indicated<br>also for<br>immediat<br>e loading<br>when<br>good<br>primary<br>stability is<br>achieved<br>and with<br>appropriat<br>e occlusal<br>loading.<br>The 7mm<br>implants<br>are<br>intended<br>to be used | function. The<br>system is<br>intended to be<br>used in either<br>single teeth or<br>multiple teeth<br>applications. | | |
|----------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | in the<br>molar<br>region. | | | |
| Implant<br>Diameters | | C Type 3.3, 3.75,<br>4.2, 5.0, 6.0 mm<br>S Type 3.3, 3.75,<br>4.2, 5.0, 6.0 mm<br>LSA (Conical)<br>3.5, 4.3, 5.0 mm | Versatile<br>Hex 3.5,<br>3.75, 4.2,<br>4.5, 5.0,<br>6.0mm<br>Immediat<br>e Hex 3.5,<br>3.75,4.2,<br>4.5, 5.0,<br>6.0,<br>7.0mm<br>Fixation<br>Narrow<br>Platform<br>3.0mm<br>Fixation<br>Regular | Classix<br>3.3, 3.8, 4.2, 5.0,<br>6.0 Conical and<br>Hex<br>Dynamix<br>3.0, 3.3, 3.8, 4.2,<br>5.0, 6.0<br>Conical and Hex<br>Saturn<br>3.8, 4.2 Hex<br>Magix<br>3.3, 3.8, 4.2<br>Conical | Osstem Hex 3.2,<br>3.5, 3.75, 3.77,<br>4.2, 4.25, 4.4,<br>4.45, 4.6, 4.63,<br>4.65, 4.8, 4.9,<br>5.05, 5.08, 5.1,<br>5.25, 6.2, 7.1 mm | |
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| | | Platform<br>3.5,<br>3.9mm<br>Fixation<br>Wide<br>Platform<br>4.3,<br>5.0mm<br>Solution5<br>Narrow<br>Platform<br>3.25mm<br>Solution5<br>Regular<br>Platform<br>3.5,<br>4.0mm<br>Solution5<br>Wide<br>Platform<br>4.5, 5.0,<br>5.5,<br>6.0mm<br>Solution2<br>3.25mm | | |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Implant<br>Lengths | C Type 8, 10, 11.5,<br>13, 16 mm<br>No 16 in 5 or 6mm<br>diameter.<br>18mm (3.75 only)<br>S Type 8, 10, 11.5,<br>13, 16 mm<br>No 16 in 6mm<br>diameter.<br>18mm (3.75 and<br>4.2 only)<br>LSA (conical) 8, 10,<br>11.5, 13, 15 mm<br>No 15 in 5mm<br>diameter. | Versatile<br>Hex 8, 10,<br>11.5, 13,<br>16, 18 (4.2<br>only), 20<br>(4.2<br>only)mm<br>Immediat<br>e Hex 8<br>(no 3.5<br>diameter)<br>10, 11.5,<br>13, 16mm<br>7.00<br>diameter<br>not in<br>11.5, 13<br>or 16mm. | Classix<br>6,8,10,11.5, 13,<br>16 no 3.3 or 3.8<br>in 6, no 3.3 in 8,<br>no 5 in 16 and<br>no 6 in 13 or 16<br>Dynamix<br>6,8,10,11.5,13,1<br>6 no 3.0 3.3 or<br>3.8 in 6, no 3.3<br>or 3.8 in 8, no<br>13 in 6 and no 5<br>or 6 in 16<br>Saturn<br>8,10,11.5,13,16<br>Magix | Osstem<br>6.2,7.0,8.5,10,11.<br>5,13,15,18 |
| | Fixation<br>Narrow<br>Platform<br>10, 11.5,<br>13, 15mm<br>Fixation<br>Regular<br>Platform<br>8.5, 10,<br>11.5, 13,<br>15, 18mm<br>Fixation<br>Wide<br>Platform<br>8.5, 10,<br>11.5, 13,<br>15, 18mm<br>Solution5<br>Narrow<br>Platform<br>10,11.5,<br>13, 15mm<br>Solution5<br>Regular<br>Platform<br>7.0 (4.0 diameter only), 8.5,<br>10, 11.5,<br>13, 15mm<br>Solution5<br>Wide<br>Platform<br>7.0, 8.5,<br>10, 11.5,<br>13, 15mm<br>Solution2<br>10,<br>11.5,13<br>16mm | 8,10,11.5,13 no<br>3.3 in 8 | | |
| Material of<br>devices<br>included in<br>the<br>submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI | |
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| Type of<br>abutment and<br>maximum<br>angulation | Pre-manufactured<br>abutments of no<br>more than $25^\circ$ and<br>Multi-Units of no<br>more than $18^\circ$ | Pre-<br>manufact<br>ured<br>abutment<br>s of no<br>more than<br>$25^\circ$ and<br>Multi-<br>Units of<br>no more<br>than $30^\circ$ | Pre-<br>manufactured<br>of no more than<br>$25^\circ$ | Pre-<br>manufactured of<br>no more than 25 |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------|
| Interface<br>type/shape | Internal hex,<br>conical | Internal<br>hex,<br>conical | Internal hex,<br>conical | Internal hex |
| Surface<br>Treatment | Alumina blasted<br>and acid etched | HA<br>blasted<br>and<br>double<br>acid<br>etched | Alumina blasted<br>and acid etched | Sand blasted and<br>acid etched |
| Post Surface<br>Treatment<br>Cleanliness<br>Demonstrated | Yes | Yes | Yes | Yes |
| | Surcam Dental Implant System | Surgikor Dental Implant System K182615 | Cortex Dental Implants K090709 & K163385 | OsseOne K182293 | Reference device for individual devices |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cover screw | Cover screws | Cover screws | Cover screws | | |
| Straight Multi-Unit Abutments in Hex and Conical | Straight multi-unit conical NP and RP in heights of 1.35, 2.35, 3.35, 4.35, 5.35 in NP platform diameter of 3.0 and in heights of 1.3, 2.3, 3.3, 4.3, 5.3mm in RP platform diameter 4.3mm Height above platform 2.15mm | Multi-unit abutments in heights of 1,2,3 and 4 mm in conical platform diameters of 3.0, 3.5, and 4.3 plus hex platform diameter of 3.75 | Straight Multi-unit Abutments in heights of 1,2,3,4 and 5 mm | | Straumann K191123 straight multi- unit in gingival height of 5.5mm |
| | Straight multi-unit IH<br>in gingival heights of<br>1.2, 2.2, 3.2, 4.2, 5.2<br>mm in diameter<br>5.0mm and in gingival<br>heights of<br>1.17,2.17.3,4,5mm<br>diameter 5.0mm<br>Height above platform<br>2.2mm | Height<br>above<br>platform<br>2.2mm | | | |
| 18° Angled<br>Multi-Unit<br>Abutments | IH Multi System<br>Angled multi-unit 18°<br>in 3.75mm diameter in<br>regular and<br>overdenture versions.<br>With total heights of<br>5.7, 6.5, 7.8mm for<br>regular and 5.7, 6.5,<br>7.6, 8.85mm for<br>overdenture and with<br>gingival heights of<br>0.55, 1.35, 2.63mm for<br>regular and 0.54, 1.3,<br>2.35, 3.57mm for<br>overdenture. | Multi-unit<br>abutments<br>in heights of<br>1,2,3 and 4<br>mm in<br>conical<br>diameters of<br>3.0, 3.5, and<br>4.3 | Angled<br>Multi-Unit<br>Abutments<br>18° and 30°<br>in heights of<br>1,2,34 and 5<br>mm | | Dentsply<br>Sirona<br>K163350<br>Multibase<br>Abutments EV<br>2-piece<br>abutments<br>with threaded<br>cap<br>3.6, 4.2, 4.8<br>mm diameter<br>in 17° and 30°<br>cuff heights of<br>1.5, 2.5 mm |
| Healing<br>Caps 4.5<br>diameter | IH Slim healing cap 4.5<br>x 8.2, 9.2, 10.2, 11.2,<br>12.2mm total heights<br>Cuff heights 3.17, 4.17,<br>5.17, 6.17, 7.17mm<br>and IH Slim healing cap<br>4.5 with total heights<br>9.05 or 10.05mm | RP 4.3mm<br>diameter<br>healing cap<br>in 2,3,4,5,6<br>and 7mm<br>height with<br>total heights<br>of 7.4, 8.3,<br>9.3, 10.3,<br>11.3, 12.3<br>mm<br>Hex 4.3mm<br>diameter<br>healing cap<br>in<br>2,3,4,5,6mm<br>cuff heights<br>total heights<br>6.7, 7.7, 8.7,<br>9.7, 10.7,<br>11.7 mm | Healing Cap<br>Abutments<br>4.6mm in<br>2,3,4,5,6and<br>7 mm | 4.6mm<br>healing cap<br>cuff heights<br>2,3,4,5,6,7<br>mm total<br>heights 6.9,<br>7.9, 8.9, 9.9,<br>10.9, 11,9 mm | |
| Healing<br>Caps 5.5<br>diameter<br>IH | Healing cap 5.5 with<br>total heights of 7.5,<br>8.1, 9.05,10.05,11.05<br>mm<br>Concave healing cap<br>5.5 with total heights<br>of 7.95, 8.95, 9.95,<br>10.95mm | Healing Cap<br>Abutments<br>in 5.6mm in<br>2,3,4,5, and<br>6mm cuff<br>height | K182293<br>5.5 wide<br>healing cap<br>cuff heights<br>2,3,4,5,6,7<br>mm and total<br>heights 7.1,<br>8.1, 9.1, 10.1,<br>11.1, 12.1 mm | | |
| Healing<br>Caps extra<br>slim 3.50<br>diameter<br>IH | Extra slim healing cap<br>3.5 with total heights<br>of 6.9, 7.9, 8.9 mm | Healing Cap<br>Abutments<br>in 3.8mm in<br>2,3,4,5,6,and<br>7 mm cuff<br>heights | | | |
| Healing<br>Cap<br>narrow<br>emergence<br>3.6mm<br>conical NP<br>& RP | Healing cap NP & RP<br>3.6 with total heights<br>of 8.3, 10.3, 12.3 mm<br>& heights above<br>platform of 2.95, 4.95,<br>6.95 mm | NP Healing<br>Cap<br>Abutments<br>in 3.8mm in<br>2,3,4,5,6,and<br>7 mm cuff<br>height | 3.8mm<br>healing cap<br>cuff heights<br>3,4,5,6,7 mm<br>total heights<br>7.85, 8.85,<br>9.85, 10.85,<br>11.85 mm | | |
| Healing<br>Cap 5.0<br>conical NP<br>& RP | Healing cap NP & RP<br>5.0 with total heights<br>of 8.3, 10.3, 12.3mm &<br>heights above<br>platform of 2.95, 4.95,<br>6.95 NP or 2.8, 4.8,<br>6.8mm RP | Healing cap<br>conical RP<br>5.0 with<br>total heights<br>of 8.3, 9.3,<br>10.3, 11.3,<br>12.3 mm | 5.5mm<br>healing cap<br>cuff heights<br>2,3,4,5,6,7<br>mm total<br>heights 7.1,<br>8.1, 9.1, 10.1,<br>11.1, 12.1 mm | | |
| Healing<br>Cap Wide<br>6.3mm IH | Healing cap wide IH<br>6,3 with total heights<br>of 8, 9, 9.6 mm | Wide<br>emergence<br>Hex healing<br>cap 6.3 in<br>total heights<br>of 6.7, 7.7,<br>8.7, 9.7,<br>10.7, 11.7<br>mm | 6.3mm<br>healing cap<br>Cuff heights<br>2,3,4,5 mm<br>total heights<br>6.85, 7.85,<br>8.85, 9.85 mm | | |
| Multi-Unit<br>Healing<br>Cap | Multi-unit healing cap<br>for all connections IH,<br>NP and RP | Single size<br>healing cap<br>for multi-<br>unit | Single size<br>healing cap<br>for multi-<br>unit | | |
| Straight<br>Anatomic<br>Abutment | IH anatomic<br>abutments cuff heights<br>1,2,3,3.7 mm total | IH Anatomic<br>straight<br>abutment | Straight<br>anatomic<br>abutments | | AB Dental<br>Implants<br>K132125 |
| in IH NP<br>RP | heights 11, 12, 13, 14 mm<br>IH Straight shoulder<br>abutments cuff heights<br>1.15,2.15,3 mm total<br>heights 11, 12, 13 mm<br>IH straight curve<br>concave abutments<br>Cuff heights 1,2,3,4<br>mm total heights 11,<br>12, 13, 14 mm<br>NP 3.0<br>RP 5.0<br>Cuff heights 1.48/1.4,<br>2.9 mm<br>Total heights NP & RP<br>10.3, 11.8 mm | with cuff<br>heights of<br>1,2,3 mm<br>total heights<br>of 9.5, 10.5,<br>11.5 mm | in cuff<br>heights<br>1,2,3,4 mm<br>total heights<br>9, 10, 11, 12<br>mm<br>Straight flat-<br>sided<br>abutment<br>4.5mm<br>diameter<br>total heights<br>of 5, 7, 9, 11,<br>13, 15mm | P3 and P3-5<br>Hex Standard<br>Titanium<br>Abutment<br>with height of<br>5,7,<br>9,11,12,15mm | |
| Straight<br>Wide<br>Anatomic<br>Abutment<br>IH | 4.5mm cuff heights<br>1,2,2.7 mm<br>Total heights 11, 12,<br>13 mm | Conical WP<br>4.3mm cuff<br>heights 1,2,3<br>mm total<br>heights 10.2,<br>11.2, 12.2<br>mm | Straight flat-<br>sided<br>abutment<br>4.5mm<br>diameter<br>total heights<br>of 5, 7, 9, 11,<br>13, 15mm | Osstem<br>K161604<br>Abutment for<br>ultra-wide<br>fixtures | |
| Angled<br>Abutment<br>15° | 15° Smooth Abutment<br>3.75mm<br>Total heights 9, 11,<br>13.5 mm<br><br>15° Smooth thin<br>3.75mm abutment<br>total height 11 mm<br><br>15° Smooth wide<br>abutment 4.5mm total<br>height 11 mm | Standard 15°<br>abutment<br>with total<br>heights 9,11,<br>13 mm | Angulated<br>15°<br>Abutment 9,<br>13 mm | | |
| Angled<br>Abutment<br>25° | 25° smooth abutment<br>3.75mm total heights<br>9.5, 11, 13.5mm | 25° non-<br>shouldered | | | |
| | | abutments<br>3.75mm<br>total heights<br>9, 11, 13mm | | | |
| Angled 15°<br>Abutment<br>with cuff<br>in IH NP<br>RP | IH 3.75mm concave<br>curve 15° abutment<br>with cuff heights<br>1.05,2,3,4 mm total<br>heights 11, 12, 13, 14<br>mm<br>NP 4.2mm<br>RP 5.0mm<br>Cuff heights 1.5,<br>3.0/2.9 mm<br>Total heights NP & RP<br>10.3, 11.8 mm<br>IH 3.75mm 15°<br>Anatomic Abutment<br>cuff height 1,1.9,3,<br>3.7mm<br>Total heights 11, 12,<br>12.5, 13.7 mm | Anatomic<br>shouldered<br>15°abutment<br>cuff heights<br>1,2,3 mm<br>total heights<br>9.53, 10.53,<br>11.53 mm | Anatomic<br>15°<br>Angulated<br>Abutment<br>with collar<br>Heights of<br>1,2,3,4 mm<br>Total heights<br>9.5, 10.5,<br>11.5, 12.5<br>mm | 15°shouldered<br>abutment cuff<br>heights 1,2,3<br>mm total<br>heights 10.99,<br>12, 12.97 mm | AB Dental<br>K132125<br>Hex RP P4 15°<br>Abutment<br>with height of<br>8,9mm<br>Hex RP P4L<br>15° Abutment<br>height of<br>13.4mm<br>Conical RP 15°<br>Abutment<br>P4C height of<br>9mm |
| | | | | | AB Dental<br>Implants<br>K132125<br>P3 and P3-5<br>Hex Standard<br>Titanium<br>Abutment<br>with height of<br>5,7,<br>9,11,12,15mm |
| Angled 25°<br>Abutment<br>with cuff<br>in IH | IH 3.75mm concave<br>curve 25° abutment<br>with cuff heights<br>1,2,3,4 mm total<br>heights 11, 12, 13, 14<br>mm<br>IH 3.75mm 25°<br>Anatomic Abutment<br>cuff height 1,2,3, 4 mm<br>Total heights 11, 12,<br>12.8, 13.5 mm<br>IH 4.5mm 25° wide<br>anatomic abutment<br>cuff height 1, 2, 2.7mm | Anatomic<br>shouldered<br>25°abutment<br>cuff heights<br>1,2,3 mm<br>total heights<br>9.53, 10.53,<br>11.53 mm | Anatomic<br>Angulated<br>Abutment<br>25° with<br>collar<br>heights of<br>1,2,3,4mm<br>Total heights<br>9.5, 10.5,<br>11.5, 12.5<br>mm | 25°<br>shouldered<br>abutment cuff<br>heights 1,2,3<br>mm total<br>heights 11.3,<br>12.2, 13.2 mm | AB Dental<br>K132125<br>Hex RP P4 25°<br>Abutment<br>with height of<br>8,9mm<br>Hex RP P4L<br>25° Abutment<br>height of<br>13.4mm<br>Conical RP 25°<br>Abutment<br>P4C height of<br>9mm |
| | | | | | AB Dental<br>Implants<br>K132125 |
| Wide 15°<br>Abutment<br>with cuff<br>in IH | Total heights 11, 12,<br>13mm | Anatomic<br>4.3 wide<br>platform 15°<br>abutment | Anatomic<br>angled 15°<br>abutments | P3 and P3-5<br>Hex Standard<br>Titanium<br>Abutment<br>with height of<br>5,7,<br>9,11,12,15mm | |
| | 4.5mm diameter IH<br>anatomic abutment<br>Cuff heights 1.25, 2 mm<br>Total heights 11, 12 mm | | cuff heights<br>1,2, or 3mm<br>total heights<br>10.23, 11.23,<br>12.23 mm | cuff heights<br>1,2,3,4 mm<br>total heights<br>9.5, 10.5,<br>11.5, 12.5<br>mm | |
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#### Conclusion:
Surcam Dental Implant System is substantially equivalent to Surgikor Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex or conical connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutment designs not found within the Surgikor Dental Implant System were found in the reference devices which have the same materials, similar indications for use and same internal hex or conical connections as the Surcam Dental Implant System. Performance testing demonstrates substantial equivalence to the identified predicate devices.
