(184 days)
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.
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 provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.
The document discusses:
- Device Name: Surcam Dental Implant System
- Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
- Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
- Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
- MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
- Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.
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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.
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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) | |
|---|---|
| ☒ 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:
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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 &Device Name | Surcam DentalImplant System | SurgikorDentalImplantSystemK182615 | Cortex DentalImplantsK090709 andK163385 | Osstem K161604 |
|---|---|---|---|---|
| Indications forUse | . The SurcamDental ImplantSystem is indicatedfor use in surgicaland restorativeapplications forplacement in thebone of the upperor lower jaw toprovide support forprosthetic devices,such as artificialteeth, in order torestore thepatient's chewingfunction. TheDental ImplantSystem is indicatedalso for immediateloading when goodprimary stability isachieved and withappropriateocclusal loading.The C Type and SType 3.3mmdiameter implantsare indicated for | Surgikor'sDentalImplantSystem isindicatedfor use insurgicalandrestorativeapplications forplacementin thebone ofthe upperor lowerjaw toprovidesupportforprostheticdevices,such asartificialteeth, inorder torestorethe | Cortex DentalImplant Systemis intended forimmediateloading whengood primarystability isachieved andwithappropriateocclusal loadingfor use insurgical (single-stage or two-stageprocedures) andrestorativeapplications forplacement inthe bone of theupper or lowerjaw to providesupport forprostheticdevice such asartificial teethand to restorethe patient'schewing | The OsstemImplant isindicated for usein partially orfully edentulousmandibles andmaxillae, insupport of singleormultiple-unitrestorationsincluding;cementedretained, screwretained, oroverdenturerestorations, andfinal ortemporaryabutmentsupport for fixedbridgework. It isintended fordelayed loading.Ultra WideFixture System isintended to beused in the molarregion. |
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| use with onlystraight abutments.Temporarycylinders must bein a splintedrestoration onlyand are not forsingle crownrestorations. | patient'schewingfunction.TheDentalImplantSystem isindicatedalso forimmediate loadingwhengoodprimarystability isachievedand withappropriate occlusalloading.The 7mmimplantsareintendedto be used | function. Thesystem isintended to beused in eithersingle teeth ormultiple teethapplications. | ||||
|---|---|---|---|---|---|---|
| in themolarregion. | ||||||
| ImplantDiameters | C Type 3.3, 3.75,4.2, 5.0, 6.0 mmS Type 3.3, 3.75,4.2, 5.0, 6.0 mmLSA (Conical)3.5, 4.3, 5.0 mm | VersatileHex 3.5,3.75, 4.2,4.5, 5.0,6.0mmImmediate Hex 3.5,3.75,4.2,4.5, 5.0,6.0,7.0mmFixationNarrowPlatform3.0mmFixationRegular | Classix3.3, 3.8, 4.2, 5.0,6.0 Conical andHexDynamix3.0, 3.3, 3.8, 4.2,5.0, 6.0Conical and HexSaturn3.8, 4.2 HexMagix3.3, 3.8, 4.2Conical | 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 |
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| Platform3.5,3.9mmFixationWidePlatform4.3,5.0mmSolution5NarrowPlatform3.25mmSolution5RegularPlatform3.5,4.0mmSolution5WidePlatform4.5, 5.0,5.5,6.0mmSolution23.25mm | ||||
|---|---|---|---|---|
| ImplantLengths | C Type 8, 10, 11.5,13, 16 mmNo 16 in 5 or 6mmdiameter.18mm (3.75 only)S Type 8, 10, 11.5,13, 16 mmNo 16 in 6mmdiameter.18mm (3.75 and4.2 only)LSA (conical) 8, 10,11.5, 13, 15 mmNo 15 in 5mmdiameter. | VersatileHex 8, 10,11.5, 13,16, 18 (4.2only), 20(4.2only)mmImmediate Hex 8(no 3.5diameter)10, 11.5,13, 16mm7.00diameternot in11.5, 13or 16mm. | Classix6,8,10,11.5, 13,16 no 3.3 or 3.8in 6, no 3.3 in 8,no 5 in 16 andno 6 in 13 or 16Dynamix6,8,10,11.5,13,16 no 3.0 3.3 or3.8 in 6, no 3.3or 3.8 in 8, no13 in 6 and no 5or 6 in 16Saturn8,10,11.5,13,16Magix | Osstem6.2,7.0,8.5,10,11.5,13,15,18 |
| FixationNarrowPlatform10, 11.5,13, 15mmFixationRegularPlatform8.5, 10,11.5, 13,15, 18mmFixationWidePlatform8.5, 10,11.5, 13,15, 18mmSolution5NarrowPlatform10,11.5,13, 15mmSolution5RegularPlatform7.0 (4.0 diameter only), 8.5,10, 11.5,13, 15mmSolution5WidePlatform7.0, 8.5,10, 11.5,13, 15mmSolution210,11.5,1316mm | 8,10,11.5,13 no3.3 in 8 | |||
| Material ofdevicesincluded inthesubmission | Ti-6AL-4V ELI | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
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| Type ofabutment andmaximumangulation | Pre-manufacturedabutments of nomore than $25^\circ$ andMulti-Units of nomore than $18^\circ$ | Pre-manufacturedabutments of nomore than$25^\circ$ andMulti-Units ofno morethan $30^\circ$ | Pre-manufacturedof no more than$25^\circ$ | Pre-manufactured ofno more than 25 |
|---|---|---|---|---|
| Interfacetype/shape | Internal hex,conical | Internalhex,conical | Internal hex,conical | Internal hex |
| SurfaceTreatment | Alumina blastedand acid etched | HAblastedanddoubleacidetched | Alumina blastedand acid etched | Sand blasted andacid etched |
| Post SurfaceTreatmentCleanlinessDemonstrated | 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 IHin gingival heights of1.2, 2.2, 3.2, 4.2, 5.2mm in diameter5.0mm and in gingivalheights of1.17,2.17.3,4,5mmdiameter 5.0mmHeight above platform2.2mm | Heightaboveplatform2.2mm | ||||
| 18° AngledMulti-UnitAbutments | IH Multi SystemAngled multi-unit 18°in 3.75mm diameter inregular andoverdenture versions.With total heights of5.7, 6.5, 7.8mm forregular and 5.7, 6.5,7.6, 8.85mm foroverdenture and withgingival heights of0.55, 1.35, 2.63mm forregular and 0.54, 1.3,2.35, 3.57mm foroverdenture. | Multi-unitabutmentsin heights of1,2,3 and 4mm inconicaldiameters of3.0, 3.5, and4.3 | AngledMulti-UnitAbutments18° and 30°in heights of1,2,34 and 5mm | DentsplySironaK163350MultibaseAbutments EV2-pieceabutmentswith threadedcap3.6, 4.2, 4.8mm diameterin 17° and 30°cuff heights of1.5, 2.5 mm | |
| HealingCaps 4.5diameter | IH Slim healing cap 4.5x 8.2, 9.2, 10.2, 11.2,12.2mm total heightsCuff heights 3.17, 4.17,5.17, 6.17, 7.17mmand IH Slim healing cap4.5 with total heights9.05 or 10.05mm | RP 4.3mmdiameterhealing capin 2,3,4,5,6and 7mmheight withtotal heightsof 7.4, 8.3,9.3, 10.3,11.3, 12.3mmHex 4.3mmdiameterhealing capin2,3,4,5,6mmcuff heightstotal heights6.7, 7.7, 8.7,9.7, 10.7,11.7 mm | Healing CapAbutments4.6mm in2,3,4,5,6and7 mm | 4.6mmhealing capcuff heights2,3,4,5,6,7mm totalheights 6.9,7.9, 8.9, 9.9,10.9, 11,9 mm | |
| HealingCaps 5.5diameterIH | Healing cap 5.5 withtotal heights of 7.5,8.1, 9.05,10.05,11.05mmConcave healing cap5.5 with total heightsof 7.95, 8.95, 9.95,10.95mm | Healing CapAbutmentsin 5.6mm in2,3,4,5, and6mm cuffheight | K1822935.5 widehealing capcuff heights2,3,4,5,6,7mm and totalheights 7.1,8.1, 9.1, 10.1,11.1, 12.1 mm | ||
| HealingCaps extraslim 3.50diameterIH | Extra slim healing cap3.5 with total heightsof 6.9, 7.9, 8.9 mm | Healing CapAbutmentsin 3.8mm in2,3,4,5,6,and7 mm cuffheights | |||
| HealingCapnarrowemergence3.6mmconical NP& RP | Healing cap NP & RP3.6 with total heightsof 8.3, 10.3, 12.3 mm& heights aboveplatform of 2.95, 4.95,6.95 mm | NP HealingCapAbutmentsin 3.8mm in2,3,4,5,6,and7 mm cuffheight | 3.8mmhealing capcuff heights3,4,5,6,7 mmtotal heights7.85, 8.85,9.85, 10.85,11.85 mm | ||
| HealingCap 5.0conical NP& RP | Healing cap NP & RP5.0 with total heightsof 8.3, 10.3, 12.3mm &heights aboveplatform of 2.95, 4.95,6.95 NP or 2.8, 4.8,6.8mm RP | Healing capconical RP5.0 withtotal heightsof 8.3, 9.3,10.3, 11.3,12.3 mm | 5.5mmhealing capcuff heights2,3,4,5,6,7mm totalheights 7.1,8.1, 9.1, 10.1,11.1, 12.1 mm | ||
| HealingCap Wide6.3mm IH | Healing cap wide IH6,3 with total heightsof 8, 9, 9.6 mm | WideemergenceHex healingcap 6.3 intotal heightsof 6.7, 7.7,8.7, 9.7,10.7, 11.7mm | 6.3mmhealing capCuff heights2,3,4,5 mmtotal heights6.85, 7.85,8.85, 9.85 mm | ||
| Multi-UnitHealingCap | Multi-unit healing capfor all connections IH,NP and RP | Single sizehealing capfor multi-unit | Single sizehealing capfor multi-unit | ||
| StraightAnatomicAbutment | IH anatomicabutments cuff heights1,2,3,3.7 mm total | IH Anatomicstraightabutment | Straightanatomicabutments | AB DentalImplantsK132125 | |
| in IH NPRP | heights 11, 12, 13, 14 mmIH Straight shoulderabutments cuff heights1.15,2.15,3 mm totalheights 11, 12, 13 mmIH straight curveconcave abutmentsCuff heights 1,2,3,4mm total heights 11,12, 13, 14 mmNP 3.0RP 5.0Cuff heights 1.48/1.4,2.9 mmTotal heights NP & RP10.3, 11.8 mm | with cuffheights of1,2,3 mmtotal heightsof 9.5, 10.5,11.5 mm | in cuffheights1,2,3,4 mmtotal heights9, 10, 11, 12mmStraight flat-sidedabutment4.5mmdiametertotal heightsof 5, 7, 9, 11,13, 15mm | P3 and P3-5Hex StandardTitaniumAbutmentwith height of5,7,9,11,12,15mm | |
| StraightWideAnatomicAbutmentIH | 4.5mm cuff heights1,2,2.7 mmTotal heights 11, 12,13 mm | Conical WP4.3mm cuffheights 1,2,3mm totalheights 10.2,11.2, 12.2mm | Straight flat-sidedabutment4.5mmdiametertotal heightsof 5, 7, 9, 11,13, 15mm | OsstemK161604Abutment forultra-widefixtures | |
| AngledAbutment15° | 15° Smooth Abutment3.75mmTotal heights 9, 11,13.5 mm15° Smooth thin3.75mm abutmenttotal height 11 mm15° Smooth wideabutment 4.5mm totalheight 11 mm | Standard 15°abutmentwith totalheights 9,11,13 mm | Angulated15°Abutment 9,13 mm | ||
| AngledAbutment25° | 25° smooth abutment3.75mm total heights9.5, 11, 13.5mm | 25° non-shouldered | |||
| abutments3.75mmtotal heights9, 11, 13mm | |||||
| Angled 15°Abutmentwith cuffin IH NPRP | IH 3.75mm concavecurve 15° abutmentwith cuff heights1.05,2,3,4 mm totalheights 11, 12, 13, 14mmNP 4.2mmRP 5.0mmCuff heights 1.5,3.0/2.9 mmTotal heights NP & RP10.3, 11.8 mmIH 3.75mm 15°Anatomic Abutmentcuff height 1,1.9,3,3.7mmTotal heights 11, 12,12.5, 13.7 mm | Anatomicshouldered15°abutmentcuff heights1,2,3 mmtotal heights9.53, 10.53,11.53 mm | Anatomic15°AngulatedAbutmentwith collarHeights of1,2,3,4 mmTotal heights9.5, 10.5,11.5, 12.5mm | 15°shoulderedabutment cuffheights 1,2,3mm totalheights 10.99,12, 12.97 mm | AB DentalK132125Hex RP P4 15°Abutmentwith height of8,9mmHex RP P4L15° Abutmentheight of13.4mmConical RP 15°AbutmentP4C height of9mm |
| AB DentalImplantsK132125P3 and P3-5Hex StandardTitaniumAbutmentwith height of5,7,9,11,12,15mm | |||||
| Angled 25°Abutmentwith cuffin IH | IH 3.75mm concavecurve 25° abutmentwith cuff heights1,2,3,4 mm totalheights 11, 12, 13, 14mmIH 3.75mm 25°Anatomic Abutmentcuff height 1,2,3, 4 mmTotal heights 11, 12,12.8, 13.5 mmIH 4.5mm 25° wideanatomic abutmentcuff height 1, 2, 2.7mm | Anatomicshouldered25°abutmentcuff heights1,2,3 mmtotal heights9.53, 10.53,11.53 mm | AnatomicAngulatedAbutment25° withcollarheights of1,2,3,4mmTotal heights9.5, 10.5,11.5, 12.5mm | 25°shoulderedabutment cuffheights 1,2,3mm totalheights 11.3,12.2, 13.2 mm | AB DentalK132125Hex RP P4 25°Abutmentwith height of8,9mmHex RP P4L25° Abutmentheight of13.4mmConical RP 25°AbutmentP4C height of9mm |
| AB DentalImplantsK132125 | |||||
| Wide 15°Abutmentwith cuffin IH | Total heights 11, 12,13mm | Anatomic4.3 wideplatform 15°abutment | Anatomicangled 15°abutments | P3 and P3-5Hex StandardTitaniumAbutmentwith height of5,7,9,11,12,15mm | |
| 4.5mm diameter IHanatomic abutmentCuff heights 1.25, 2 mmTotal heights 11, 12 mm | cuff heights1,2, or 3mmtotal heights10.23, 11.23,12.23 mm | cuff heights1,2,3,4 mmtotal heights9.5, 10.5,11.5, 12.5mm |
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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.
§ 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.