IDCAM Dental Implants

K200329 · Implants Diffusion International · DZE · Apr 22, 2021 · Dental

Device Facts

• Record ID: K200329
• Device Name: IDCAM Dental Implants
• Applicant: Implants Diffusion International
• Product Code: DZE · Dental
• Decision Date: Apr 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading, These implants can also be used for loading after a conventional healing period.

Device Story

IDCAM Dental Implants are tapered conical endosseous implants; available in two designs: IDCAM M (mini-threads) and IDCAM ST (large flat top threads, sharp bottom threads). Implants feature convex bottoms and grit-blasted, acid-etched surfaces. System includes various abutments (Morse taper, angled, multi-unit, ball attachments, provisional) and healing caps. Used by dental professionals in clinical settings for surgical placement in jaw arches to support prosthetic restorations. Implants provide structural foundation for artificial teeth; immediate or delayed loading based on primary stability. Benefits include restoration of chewing function and esthetics. Abutments connect via Morse taper and screw; multi-unit abutments support splinted restorations. Device output is the mechanical support for dental prosthetics.

Clinical Evidence

Bench testing only. Includes dynamic fatigue testing per ISO 14801, surface analysis, and cytotoxicity testing per ISO 10993-5. Sterilization validation performed per ISO 11137-1,-2,-3 (implants) and ISO 17665-2/ANSI/AAMI ST79 (abutments). Package integrity and accelerated aging per ISO 11607-1,-2. Endotoxin testing per USP 161.

Technological Characteristics

Materials: ASTM F136 Ti 6Al 4V ELI titanium alloy. Surface: Grit blasted and acid etched. Connection: Conical (Morse taper). Sterilization: Gamma irradiation (implants), steam sterilization (abutments). Dimensions: Diameters 3.7-5.2mm, lengths 8.5-14.4mm. Mechanical design: Tapered conical with varying thread profiles.

Indications for Use

Indicated for patients requiring endosseous dental implants in upper or lower jaw arches to support prosthetic devices (artificial teeth) for restoration of esthetics and chewing function. Suitable for single or multiple unit restorations on splinted applications. Supports immediate loading with good primary stability and appropriate occlusive loading, or loading after conventional healing.

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

• SpiralTech Dental Implant System Ultimate Conical (K170372)

Reference Devices

• Cortex (K090709)
• Cortex (K163385)
• Nobel Biocare (K161435)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.

Implants Diffusion International % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K200329

Trade/Device Name: IDCAM Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 18, 2021 Received: March 23, 2021

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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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 Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200329

Device Name IDCAM Dental Implants

#### Indications for Use (Describe)

IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading, These implants can also be used for loading after a conventional healing period.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: underline;"><b>Prescription Use (Part 21 CFR 801 Subpart D)</b></span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div style="text-align: center;">☑</div> | <div style="text-align: center;">☐</div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510k Summary April 21, 2021 IDCAM Dental Implants K200329

Name and address: Implants Diffusion International 23 rue Emile Zola Montreuil France 93100 Contact Person: Rony Boukhris Phone Number: [phone] Name of device: IDCAM Dental Implants 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 [phone] [e-mail]

Device Description: The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.

ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival

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heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.

PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.

Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.

Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).

Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.

Indications for Use: IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth , in order to restore patients esthetics and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They

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are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. IDCAM implants exhibited a run out limit equivalent to other implant systems. Surface modification information was provided per the FDA Guidance Document for Endosseous Dental Implants and Abutments. Surface analysis and cytotoxicity testing per ISO 10993-5 was done to show the surface treatment does not adversely change the biocompatibility of the materials are ones common in dental implant systems and are appropriate materials for devices used with dental implants. Implants and abutments are made of titanium alloy which meets ASTM F136. Sterilization validation was conducted on the implants per ISO 11137-1,-2,and -3. Abutment steam sterilization validation was done per ISO 17665-2 and ANSI/AAMI ST79. Package integrity testing and accelerated aging were conducted per ISO 11607-1 and -2. Endotoxin testing according to USP 161 was conducted.

Primary Predicate Device: SpiralTech Dental Implant System Ultimate Conical K170372 Reference Predicates: Cortex K090709 and K163385

## Substantial Equivalence:

| Implant System<br>Comparison Table | ID CAM Dental<br>Implants (Subject<br>Device) | SpiralTech Dental<br>Implant System<br>K170372<br>Ultimate Conical |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | IDCAM Dental<br>Implants are<br>endosseous implants<br>intended to be<br>surgically placed in the<br>upper or lower jaw<br>arches to provide<br>support for prosthetic<br>devices, such as an<br>artificial tooth , in<br>order to restore<br>patients esthetics and<br>chewing function. | The Spiraltech Dental<br>Implants are<br>endosseous implants<br>intended to be<br>surgically placed in<br>the upper or lower<br>jaw arches to provide<br>support for prosthetic<br>devices, such as an<br>artificial tooth, in<br>order to restore<br>patient's esthetics and<br>chewing function.<br>Spiraltech implants<br>are intended for single |
| | IDCAM implants are | or multiple unit |
| | intended for single or | restorations on |
| | multiple unit | splinted or non- |
| | restorations on | splinted applications. |
| | splinted or non- | The implants ESi |
| | splinted applications. | Dynamic and Ultimate |
| | | are intended for |
| | They are intended for | immediate loading |
| | immediate loading | when good primary |
| | when good primary | stability is achieved,<br>and with appropriate |
| | stability is achieved, | occlusive loading. |
| | and with appropriate | These implants [along |
| | occlusive loading. | with Premium and |
| | These implants can | One Piece] can also be |
| | also be used for | used for loading after |
| | loading after a | a conventional healing |
| | conventional healing | period. |
| | period. | Solo One Piece 3.0 |
| | | and 3.3 implants, |
| | | Ultimate (conical) 3.0 |
| | | implants, and ESi |
| | | (conical) 3.0 implants |
| | | are intended to |
| | | replace a lateral |
| | | incisor in the maxilla |
| | | and/or a central or |
| | | lateral incisor in the |
| | | mandible. Mandibular |
| | | central and lateral |
| | | incisors must be |
| | | splinted if using two |
| | | or more 3.0 and/or<br>3.3 implants adjacent |
| | | to one another. |
| Material | Ti6Al4V | Ti6Al4V |
| | IDCAM M | |
| Diameter of Implants | 4.2, 5.2 | 3.0, 3.5, 4.3, 5.0, 6.0 |
| Implant Lengths | 8.5, 9.4, 11.4, 14.4 | 8, 10, 11.5, 13, 15<br>(3.0mm diameter not<br>in 8 length) |
| Surface Treatment | SLA | SLA or RBM |
| Sterilization of Implants | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation |
| Sterilization of abutments | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them |
| Connection | Conical | Conical |
| Spiral Implant Design | IDCAM M | Ultimate Conical |
| ISO 14801 Fatigue Test | Run out limit is the same or higher than those of other implant systems | Run out limit is comparable to other implant systems. |
| IDCAM ST | | |
| Diameter of Implants | 3.7, 3.9, 4.2, 5.2 | 3.0, 3.5, 4.3, 5.0, 6.0 |
| Implant Lengths | 9.4, 11.4, 14.4 | 8, 10, 11.5, 13, 15 (3.0mm diameter not in 8 length) |
| Surface Treatment | SLA | SLA or RBM |
| Sterilization of Implants | Provided sterile by gamma irradiation | Provided sterile by gamma irradiation |
| Sterilization of abutments | Provided non-sterile with instructions for user to sterilize them | Provided non-sterile with instructions for user to sterilize them |
| Connection | Conical | Conical |
| Spiral Implant Design | IDCAM ST | Ultimate Conical |
| ISO 14801 Fatigue Test | Run out limit is the same or higher than those of other implant systems | Run out limit is comparable to other implant systems. |

IDCAM Dental Implants are substantially equivalent to SpiralTech Dental Implant System in indications for use, materials, design, and fatigue performance,

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| Conical Implant<br>Parts | IDCAM Dental<br>Implants | SpiralTech Dental<br>Implant System<br>Conical<br>Connection Parts | Cortex K090709<br>and K163385<br>Conical<br>Connection<br>Parts |
|--------------------------|--------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------|
| Cover screw | Cover screw for<br>IDCAM 3.6mm<br>diameter | Cover screw NP<br>and RP | |

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| Abutment screw | IDCAM and<br>IDUnit 3.6mm<br>abutment screws | NP and RP<br>abutment screws | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Multi-Unit<br>Abutments* | IDUnit 3.6mm<br>diameter at<br>platform 4.9mm<br>diameter at top<br>of shoulder<br>abutments in<br>gingival heights of<br>1,2.5, 4, and 6<br>mm | | NP, RP, and WP<br>Multi-unit<br>abutments in<br>heights of 1, 2, 3,<br>4, and 5 mm |
| 17° Multi-Unit<br>Abutments * | IDUnit 17° Multi-<br>Unit Abutments<br>3.6mm diameter<br>at platform<br>4.9mm diameter<br>at top of shoulder<br>in gingival heights<br>of 1.35,3.02, 5<br>mm | | NP and RP 18°<br>Multi-Unit<br>Abutments<br>in heights of 1, 2,<br>3, 4, 5 mm |
| 30° Multi-Unit<br>Abutments * | IDUnit 30° Multi-<br>Unit Abutments<br>3.6mm diameter<br>at platform<br>4.9mm diameter<br>at top of shoulder<br>in gingival heights<br>of 1,3.01, 5 mm | | NP and RP 30°<br>Multi-Unit<br>Abutments<br>in heights of 1, 2,<br>3, 4, 5 mm |
| Ball<br>attachments* | 3.5 mm diameter<br>at platform in<br>gingival heights of<br>1, 2.5, 4, and<br>6mm | NP and RP Ball<br>attachments in<br>heights of<br>1,2,3,4,5, and<br>6mm | |
| Healing Caps NP | Cylindrical<br>Healing Cap<br>Narrow 3.2mm<br>diameter in<br>3.5,5.5 mm<br>gingival heights | NP Healing Cap in<br>2,3,4,5 and 6 mm<br>height | |
| Healing Caps RP | Cylindrical<br>Healing Cap<br>Regular 4mm | RP Healing Cap in<br>2,3,4,5, and 6<br>mm height | |
| | diameter in 2,4, 6<br>and 8 mm<br>gingival heights | | |
| Healing Cap WP | Cylindrical<br>Healing Cap Wide<br>5mm diameter in<br>2, 4, 6, 8mm<br>gingival heights | | 5.8mm Healing<br>cap in 3,4,5,6<br>mm |
| Conical Profile<br>Healing Cap<br>Regular | 3.6mm diameter<br>at platform 4mm<br>cone top<br>diameter and 6<br>mm gingival<br>height | NP Healing Cap in<br>2,3,4,5 and 6 mm<br>height | |
| Conical Profile<br>Healing Cap Wide | 3.6mm diameter<br>at platform 6mm<br>cone top<br>diameter and 6<br>mm gingival<br>height | NP Healing Cap in<br>2,3,4,5 and 6 mm<br>height | |
| Healing Cap for<br>Multi-Unit | IDUnit healing<br>cap | | Titanium healing<br>cap for multi-<br>unit 5.0mm<br>diameter 4.8mm<br>height |
| Straight<br>Abutment | Morse taper cone<br>straight<br>abutment<br>3.6,4.2mm<br>diameter at<br>platform<br>gingival heights of<br>1.4, 3,5 mm | RP Flat Standard<br>Abutment with<br>height of 6,7,9<br>and 11 mm | |
| WP Shoulder<br>Abutment | Morse taper<br>shouldered<br>straight cone<br>abutment 5.4mm<br>diameter at<br>upper platform<br>3.6 mm diameter<br>at platform<br>bottom gingival | NP and RP Flat<br>with straight<br>shoulder<br>abutment in<br>heights of 1,2,<br>and 3 mm | WP anatomic<br>abutment<br>5.8mm diameter<br>in heights of 1, 2,<br>3, and 4mm |

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| NP and RP 7°<br>Abutment | heights of 1.3,2.2<br>3.2, 5 mm<br>Height between<br>platform top and<br>bottom 3.7 +<br>gingival height<br>Morse taper 7°<br>angled cone<br>abutment<br>3.6 and 4.2mm<br>diameter with<br>gingival heights of<br>1.4,3,5 mm | NP and RP 15°<br>Abutment with<br>heights of 1,2,3<br>mm | NP and RP 15°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| WP 7° Abutment<br>with shoulder | Morse taper 7°<br>angled cone<br>abutment with<br>shoulder<br>5.4 mm diameter<br>at upper platform<br>3.6mm diameter<br>at platform<br>bottom<br>gingival heights of<br>0.9,3,5 mm<br>Height between<br>platform top and<br>bottom 3.7 +<br>gingival height | | WP 15°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm |
| NP and RP 15°<br>Abutment | Morse taper 15°<br>angled cone<br>abutment<br>3.6 and 4.2mm<br>diameter with<br>gingival heights of<br>1.63, 3, 5 mm | NP and RP 15°<br>Abutment with<br>heights of 1,2,3<br>mm | NP and RP 15°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm |
| WP 15°<br>Abutment with<br>shoulder | Morse taper 15°<br>angled cone<br>abutment with<br>shoulder<br>5.4 mm diameter<br>at upper platform<br>3.6mm diameter<br>at platform<br>bottom | | WP 15°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm |
| NP and RP 23°<br>Abutment | gingival heights of<br>0.9, 2.35, 3.30,<br>5.03 mm<br>Height between<br>platform top and<br>bottom 3.7 +<br>gingival height | NP and RP 25°<br>Abutment with<br>heights of 1,2,<br>and 3mm | NP and RP 25°<br>Anatomic<br>Abutment with<br>heights of 2,3, 4<br>mm |
| | Morse taper 23°<br>angled cone<br>abutment<br>3.6 and 4.2mm<br>diameter gingival<br>heights of 1.63, 3,<br>5 mm | | |
| WP 23°<br>Abutment with<br>shoulder | Morse taper 23°<br>angled cone<br>abutment with<br>shoulder<br>5.4 mm diameter<br>at upper platform<br>3.6mm diameter<br>at bottom of<br>platform<br>gingival heights of<br>0.9, 2.35, 3.3,<br>5.03 mm<br>Height between<br>platform top and<br>bottom 3.7 +<br>gingival height | | WP 25°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm |
| Locator<br>Abutments * | IDLoc attachment<br>3.6mm diameter<br>at platformi<br>gingival heights of<br>2.5,4, 5.5, and 7.5<br>mm | IPI NP and RP in<br>heights of<br>1,2,3,4,5 and 6<br>mm | |
| WP<br>Straight<br>Abutment with<br>shoulder | Plan straight<br>abutment with<br>shoulder 5.4mm<br>diameter at<br>shoulder top<br>3.6mm diameter<br>at shoulder<br>bottom | | WP anatomic<br>abutment<br>5.8mm diameter<br>in heights of 1, 2,<br>3, and 4mm |
| | gingival heights of<br>1.5 and 3mm | | |
| WP 15° angled<br>abutment with<br>shoulder | Plan 15° angled<br>abutment with<br>shoulder 5.4mm<br>diameter at<br>shoulder top<br>3.6mm diameter<br>at shoulder<br>bottom<br>gingival heights of<br>1.5 and 3mm | WP 15°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm | |
| WP 23° angled<br>abutment with<br>shoulder | Plan 23° angled<br>abutment with<br>shoulder 5.4mm<br>diameter at<br>shoulder top<br>3.6mm diameter<br>at shoulder<br>bottom<br>gingival heights of<br>1.5 and 3mm | WP 25°<br>Anatomic<br>Abutment with<br>heights of 1,2,3,<br>4 mm | |
| Temporary<br>Abutments | 3.6mm diameter<br>provisional<br>abutments in<br>rotational<br>(gingival height<br>1.5, post height<br>7.5), non-<br>rotational<br>(gingival height<br>1.5, post height<br>7.5, 4.8mm<br>diameter at top<br>of shoulder), non-<br>rotational tall<br>(gingival height<br>1.5mm, post<br>height 12.5mm,<br>4.0mm diameter<br>at top of<br>shoulder) and<br>IDUnit (4.9 mm | Nobel Biocare<br>K161435<br>Temporary Snap<br>Abutments<br>engaging, non-<br>engaging, and<br>multi-unit | |
| diameter at base, post height 10.5) | | | |

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*These models of abutments are not for single crown use.

### Conclusion:

IDCAM Dental Implants are substantially equivalent to SpiralTech Dental Implant System. They both have the same indications for use, are of the same material, and have conical connections. Performance testing demonstrates substantial equivalence to the identified predicate devices. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutments not found in the predicate device system are found in the reference device system. The design and size differences between predicate or reference devices and the subject devices are only minor differences in geometry and size so given the use, materials and technology is the same they do not change the substantial equivalence.