Predicate Devices

Reference Devices

Straumann K191123, Cortex Dental Implants K090709, Cortex Dental Implants K163385, AB Dental Implants K132125, OsseOne K182293, Dentsply Sirona K163350, Osstem K161604

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system with mechanical components and materials testing, with no mention of AI or ML.

Therapeutic

Yes
The device is described as restoring the patient's chewing function, which constitutes a therapeutic outcome.

Diagnostic

No

This device is a dental implant system used for surgical and restorative applications to provide support for prosthetic devices, restoring chewing function. It is a treatment device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like endosseous dental implants, abutments, cover screws, and healing caps, which are hardware. The performance studies also focus on testing these physical components.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
Device Description and Intended Use: The Surcam Dental Implant System is a physical device implanted directly into the bone of the jaw to support prosthetic teeth. Its function is mechanical and structural, not diagnostic testing of bodily fluids or tissues.

The provided information clearly describes a surgical implant system, not a device for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 used in a splinted restoration only and are not for single crown restorations.

Product codes

DZE, NHA

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

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

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

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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

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.

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

Not Found

Predicate Device(s)

Surgikor Dental Implant System K182615

Reference Device(s)

Straumann K191123, Cortex Dental Implants K090709, Cortex Dental Implants K163385, AB Dental Implants K132125, OsseOne K182293, Dentsply Sirona K163350, Osstem K161604

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

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

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

1

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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.

2

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

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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:

8

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 &
Device Name | Surcam Dental
Implant System | Surgikor
Dental
Implant
System
K182615 | Cortex Dental
Implants
K090709 and
K163385 | Osstem K161604 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 and S
Type 3.3mm
diameter implants
are indicated for | Surgikor's
Dental
Implant
System is
indicated
for use in
surgical
and
restorativ
e
applicatio
ns 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 | Cortex Dental
Implant System
is intended for
immediate
loading when
good primary
stability is
achieved and
with
appropriate
occlusal loading
for use in
surgical (single-
stage or two-
stage
procedures) and
restorative
applications for
placement in
the bone of the
upper or lower
jaw to provide
support for
prosthetic
device such as
artificial teeth
and to restore
the patient's
chewing | The Osstem
Implant is
indicated for use
in partially or
fully edentulous
mandibles and
maxillae, in
support of single
or
multiple-unit
restorations
including;
cemented
retained, screw
retained, or
overdenture
restorations, and
final or
temporary
abutment
support for fixed
bridgework. It is
intended for
delayed loading.
Ultra Wide
Fixture System is
intended to be
used in the molar
region. |

9

| | | use with only
straight abutments.
Temporary
cylinders must be
in a splinted
restoration only
and are not for
single crown
restorations. | patient's
chewing
function.
The
Dental
Implant
System is
indicated
also for
immediat
e loading
when
good
primary
stability is
achieved
and with
appropriat
e occlusal
loading.
The 7mm
implants
are
intended
to be used | function. The
system is
intended to be
used in either
single teeth or
multiple teeth
applications. | | |
|----------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | in the
molar
region. | | | |
| Implant
Diameters | | C Type 3.3, 3.75,
4.2, 5.0, 6.0 mm
S Type 3.3, 3.75,
4.2, 5.0, 6.0 mm
LSA (Conical)
3.5, 4.3, 5.0 mm | Versatile
Hex 3.5,
3.75, 4.2,
4.5, 5.0,
6.0mm
Immediat
e Hex 3.5,
3.75,4.2,
4.5, 5.0,
6.0,
7.0mm
Fixation
Narrow
Platform
3.0mm
Fixation
Regular | Classix
3.3, 3.8, 4.2, 5.0,
6.0 Conical and
Hex
Dynamix
3.0, 3.3, 3.8, 4.2,
5.0, 6.0
Conical and Hex
Saturn
3.8, 4.2 Hex
Magix
3.3, 3.8, 4.2
Conical | Osstem Hex 3.2,
3.5, 3.75, 3.77,
4.2, 4.25, 4.4,
4.45, 4.6, 4.63,
4.65, 4.8, 4.9,
5.05, 5.08, 5.1,
5.25, 6.2, 7.1 mm | |

10

| | | Platform
3.5,
3.9mm
Fixation
Wide
Platform
4.3,
5.0mm
Solution5
Narrow
Platform
3.25mm
Solution5
Regular
Platform
3.5,
4.0mm
Solution5
Wide
Platform
4.5, 5.0,
5.5,
6.0mm
Solution2
3.25mm | | |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Implant
Lengths | C Type 8, 10, 11.5,
13, 16 mm
No 16 in 5 or 6mm
diameter.
18mm (3.75 only)
S Type 8, 10, 11.5,
13, 16 mm
No 16 in 6mm
diameter.
18mm (3.75 and
4.2 only)
LSA (conical) 8, 10,
11.5, 13, 15 mm
No 15 in 5mm
diameter. | Versatile
Hex 8, 10,
11.5, 13,
16, 18 (4.2
only), 20
(4.2
only)mm
Immediat
e Hex 8
(no 3.5
diameter)
10, 11.5,
13, 16mm
7.00
diameter
not in
11.5, 13
or 16mm. | Classix
6,8,10,11.5, 13,
16 no 3.3 or 3.8
in 6, no 3.3 in 8,
no 5 in 16 and
no 6 in 13 or 16
Dynamix
6,8,10,11.5,13,1
6 no 3.0 3.3 or
3.8 in 6, no 3.3
or 3.8 in 8, no
13 in 6 and no 5
or 6 in 16
Saturn
8,10,11.5,13,16
Magix | Osstem
6.2,7.0,8.5,10,11.
5,13,15,18 |
| | Fixation
Narrow
Platform
10, 11.5,
13, 15mm
Fixation
Regular
Platform
8.5, 10,
11.5, 13,
15, 18mm
Fixation
Wide
Platform
8.5, 10,
11.5, 13,
15, 18mm
Solution5
Narrow
Platform
10,11.5,
13, 15mm
Solution5
Regular
Platform
7.0 (4.0 diameter only), 8.5,
10, 11.5,
13, 15mm
Solution5
Wide
Platform
7.0, 8.5,
10, 11.5,
13, 15mm
Solution2
10,
11.5,13
16mm | 8,10,11.5,13 no
3.3 in 8 | | |
| Material of
devices
included in
the
submission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI | |

11

12

| Type of
abutment and
maximum
angulation | Pre-manufactured
abutments of no
more than $25^\circ$ and
Multi-Units of no
more than $18^\circ$ | Pre-
manufact
ured
abutment
s of no
more than
$25^\circ$ and
Multi-
Units of
no more
than $30^\circ$ | Pre-
manufactured
of no more than
$25^\circ$ | Pre-
manufactured of
no more than 25 |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------------------------------|
| Interface
type/shape | Internal hex,
conical | Internal
hex,
conical | Internal hex,
conical | Internal hex |
| Surface
Treatment | Alumina blasted
and acid etched | HA
blasted
and
double
acid
etched | Alumina blasted
and acid etched | Sand blasted and
acid etched |
| Post Surface
Treatment
Cleanliness
Demonstrated | Yes | Yes | Yes | Yes |

	Surcam Dental Implant System	Surgikor Dental Implant System K182615	Cortex Dental Implants K090709 & K163385	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
in gingival heights of
1.2, 2.2, 3.2, 4.2, 5.2
mm in diameter
5.0mm and in gingival
heights of
1.17,2.17.3,4,5mm
diameter 5.0mm
Height above platform
2.2mm	Height
above
platform
2.2mm
18° Angled
Multi-Unit
Abutments	IH Multi System
Angled multi-unit 18°
in 3.75mm diameter in
regular and
overdenture versions.
With total heights of
5.7, 6.5, 7.8mm for
regular and 5.7, 6.5,
7.6, 8.85mm for
overdenture and with
gingival heights of
0.55, 1.35, 2.63mm for
regular and 0.54, 1.3,
2.35, 3.57mm for
overdenture.	Multi-unit
abutments
in heights of
1,2,3 and 4
mm in
conical
diameters of
3.0, 3.5, and
4.3	Angled
Multi-Unit
Abutments
18° and 30°
in heights of
1,2,34 and 5
mm		Dentsply
Sirona
K163350
Multibase
Abutments EV
2-piece
abutments
with threaded
cap
3.6, 4.2, 4.8
mm diameter
in 17° and 30°
cuff heights of
1.5, 2.5 mm
Healing
Caps 4.5
diameter	IH Slim healing cap 4.5
x 8.2, 9.2, 10.2, 11.2,
12.2mm total heights
Cuff heights 3.17, 4.17,
5.17, 6.17, 7.17mm
and IH Slim healing cap
4.5 with total heights
9.05 or 10.05mm	RP 4.3mm
diameter
healing cap
in 2,3,4,5,6
and 7mm
height with
total heights
of 7.4, 8.3,
9.3, 10.3,
11.3, 12.3
mm
Hex 4.3mm
diameter
healing cap
in
2,3,4,5,6mm
cuff heights
total heights
6.7, 7.7, 8.7,
9.7, 10.7,
11.7 mm	Healing Cap
Abutments
4.6mm in
2,3,4,5,6and
7 mm	4.6mm
healing cap
cuff heights
2,3,4,5,6,7
mm total
heights 6.9,
7.9, 8.9, 9.9,
10.9, 11,9 mm
Healing
Caps 5.5
diameter
IH	Healing cap 5.5 with
total heights of 7.5,
8.1, 9.05,10.05,11.05
mm
Concave healing cap
5.5 with total heights
of 7.95, 8.95, 9.95,
10.95mm	Healing Cap
Abutments
in 5.6mm in
2,3,4,5, and
6mm cuff
height	K182293
5.5 wide
healing cap
cuff heights
2,3,4,5,6,7
mm and total
heights 7.1,
8.1, 9.1, 10.1,
11.1, 12.1 mm
Healing
Caps extra
slim 3.50
diameter
IH	Extra slim healing cap
3.5 with total heights
of 6.9, 7.9, 8.9 mm	Healing Cap
Abutments
in 3.8mm in
2,3,4,5,6,and
7 mm cuff
heights
Healing
Cap
narrow
emergence
3.6mm
conical NP
& RP	Healing cap NP & RP
3.6 with total heights
of 8.3, 10.3, 12.3 mm
& heights above
platform of 2.95, 4.95,
6.95 mm	NP Healing
Cap
Abutments
in 3.8mm in
2,3,4,5,6,and
7 mm cuff
height	3.8mm
healing cap
cuff heights
3,4,5,6,7 mm
total heights
7.85, 8.85,
9.85, 10.85,
11.85 mm
Healing
Cap 5.0
conical NP
& RP	Healing cap NP & RP
5.0 with total heights
of 8.3, 10.3, 12.3mm &
heights above
platform of 2.95, 4.95,
6.95 NP or 2.8, 4.8,
6.8mm RP	Healing cap
conical RP
5.0 with
total heights
of 8.3, 9.3,
10.3, 11.3,
12.3 mm	5.5mm
healing cap
cuff heights
2,3,4,5,6,7
mm total
heights 7.1,
8.1, 9.1, 10.1,
11.1, 12.1 mm
Healing
Cap Wide
6.3mm IH	Healing cap wide IH
6,3 with total heights
of 8, 9, 9.6 mm	Wide
emergence
Hex healing
cap 6.3 in
total heights
of 6.7, 7.7,
8.7, 9.7,
10.7, 11.7
mm	6.3mm
healing cap
Cuff heights
2,3,4,5 mm
total heights
6.85, 7.85,
8.85, 9.85 mm
Multi-Unit
Healing
Cap	Multi-unit healing cap
for all connections IH,
NP and RP	Single size
healing cap
for multi-
unit	Single size
healing cap
for multi-
unit
Straight
Anatomic
Abutment	IH anatomic
abutments cuff heights
1,2,3,3.7 mm total	IH Anatomic
straight
abutment	Straight
anatomic
abutments		AB Dental
Implants
K132125
in IH NP
RP	heights 11, 12, 13, 14 mm
IH Straight shoulder
abutments cuff heights
1.15,2.15,3 mm total
heights 11, 12, 13 mm
IH straight curve
concave abutments
Cuff heights 1,2,3,4
mm total heights 11,
12, 13, 14 mm
NP 3.0
RP 5.0
Cuff heights 1.48/1.4,
2.9 mm
Total heights NP & RP
10.3, 11.8 mm	with cuff
heights of
1,2,3 mm
total heights
of 9.5, 10.5,
11.5 mm	in cuff
heights
1,2,3,4 mm
total heights
9, 10, 11, 12
mm
Straight flat-
sided
abutment
4.5mm
diameter
total heights
of 5, 7, 9, 11,
13, 15mm	P3 and P3-5
Hex Standard
Titanium
Abutment
with height of
5,7,
9,11,12,15mm
Straight
Wide
Anatomic
Abutment
IH	4.5mm cuff heights
1,2,2.7 mm
Total heights 11, 12,
13 mm	Conical WP
4.3mm cuff
heights 1,2,3
mm total
heights 10.2,
11.2, 12.2
mm	Straight flat-
sided
abutment
4.5mm
diameter
total heights
of 5, 7, 9, 11,
13, 15mm	Osstem
K161604
Abutment for
ultra-wide
fixtures
Angled
Abutment
15°	15° Smooth Abutment
3.75mm
Total heights 9, 11,
13.5 mm

15° Smooth thin
3.75mm abutment
total height 11 mm

15° Smooth wide
abutment 4.5mm total
height 11 mm | Standard 15°
abutment
with total
heights 9,11,
13 mm | Angulated
15°
Abutment 9,
13 mm | | |
| Angled
Abutment
25° | 25° smooth abutment
3.75mm total heights
9.5, 11, 13.5mm | 25° non-
shouldered | | | |
| | | abutments
3.75mm
total heights
9, 11, 13mm | | | |
| Angled 15°
Abutment
with cuff
in IH NP
RP | IH 3.75mm concave
curve 15° abutment
with cuff heights
1.05,2,3,4 mm total
heights 11, 12, 13, 14
mm
NP 4.2mm
RP 5.0mm
Cuff heights 1.5,
3.0/2.9 mm
Total heights NP & RP
10.3, 11.8 mm
IH 3.75mm 15°
Anatomic Abutment
cuff height 1,1.9,3,
3.7mm
Total heights 11, 12,
12.5, 13.7 mm | Anatomic
shouldered
15°abutment
cuff heights
1,2,3 mm
total heights
9.53, 10.53,
11.53 mm | Anatomic
15°
Angulated
Abutment
with collar
Heights of
1,2,3,4 mm
Total heights
9.5, 10.5,
11.5, 12.5
mm | 15°shouldered
abutment cuff
heights 1,2,3
mm total
heights 10.99,
12, 12.97 mm | AB Dental
K132125
Hex RP P4 15°
Abutment
with height of
8,9mm
Hex RP P4L
15° Abutment
height of
13.4mm
Conical RP 15°
Abutment
P4C height of
9mm |
| | | | | | AB Dental
Implants
K132125
P3 and P3-5
Hex Standard
Titanium
Abutment
with height of
5,7,
9,11,12,15mm |
| Angled 25°
Abutment
with cuff
in IH | IH 3.75mm concave
curve 25° abutment
with cuff heights
1,2,3,4 mm total
heights 11, 12, 13, 14
mm
IH 3.75mm 25°
Anatomic Abutment
cuff height 1,2,3, 4 mm
Total heights 11, 12,
12.8, 13.5 mm
IH 4.5mm 25° wide
anatomic abutment
cuff height 1, 2, 2.7mm | Anatomic
shouldered
25°abutment
cuff heights
1,2,3 mm
total heights
9.53, 10.53,
11.53 mm | Anatomic
Angulated
Abutment
25° with
collar
heights of
1,2,3,4mm
Total heights
9.5, 10.5,
11.5, 12.5
mm | 25°
shouldered
abutment cuff
heights 1,2,3
mm total
heights 11.3,
12.2, 13.2 mm | AB Dental
K132125
Hex RP P4 25°
Abutment
with height of
8,9mm
Hex RP P4L
25° Abutment
height of
13.4mm
Conical RP 25°
Abutment
P4C height of
9mm |
| | | | | | AB Dental
Implants
K132125 |
| Wide 15°
Abutment
with cuff
in IH | Total heights 11, 12,
13mm | Anatomic
4.3 wide
platform 15°
abutment | Anatomic
angled 15°
abutments | P3 and P3-5
Hex Standard
Titanium
Abutment
with height of
5,7,
9,11,12,15mm | |
| | 4.5mm diameter IH
anatomic abutment
Cuff heights 1.25, 2 mm
Total heights 11, 12 mm | | cuff heights
1,2, or 3mm
total heights
10.23, 11.23,
12.23 mm | cuff heights
1,2,3,4 mm
total heights
9.5, 10.5,
11.5, 12.5
mm | |

13

14

15

16

17

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.