SpiralTech Dental Implant System

K170372 · Spiraltech Superior Dental Implants, Inc. · DZE · Jun 30, 2017 · Dental

Device Facts

• Record ID: K170372
• Device Name: SpiralTech Dental Implant System
• Applicant: Spiraltech Superior Dental Implants, Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spiraltech 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. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing 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 3.3 implants adjacent to one another.

Device Story

SpiralTech Dental Implant System comprises endosseous titanium implants, abutments, and closure screws; used by dental surgeons to support prosthetic teeth. Implants feature various thread designs (ESi, Ultimate, Dynamic, Premium, One Piece) and surface treatments (SLA, RBM). Input is surgical site in jaw; device provides mechanical foundation for prosthetic restoration. Abutments (straight, shoulder, angulated, ball, multiunit, temporary, healing) connect to implants via hex or conical interfaces. Temporary abutments utilize PEEK or zirconia; healing abutments utilize titanium alloy or zirconia. System supports immediate or conventional loading protocols. Clinical benefit is restoration of chewing function and esthetics. Device is used in clinical dental settings.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 11737, ISO 11137, ISO 17665), fatigue testing per ISO 14801, surface analysis (SEM/EDS), and biocompatibility testing (cytotoxicity/MEM elution). Shelf life validated via accelerated aging (ASTM F1980).

Technological Characteristics

Materials: Grade 5 titanium (Ti 6Al-4V ELI, ASTM F136), PEEK, zirconia. Surface treatments: SLA, RBM. Connection types: Hex and conical. Dimensions: 3.0-6.0mm diameter; 8-15mm length. Sterilization: Gamma radiation and moist heat. No software or electronic components.

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. Applicable for single or multiple unit restorations (splinted or non-splinted). Specific 3.0/3.3mm implants indicated for lateral incisor (maxilla) and central/lateral incisor (mandible) replacement; mandibular incisors must be splinted if adjacent. Immediate loading permitted for ESi, Dynamic, and Ultimate lines given good primary stability and appropriate occlusive loading; otherwise, conventional healing period required.

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

• Nobel Biocare (K071370)

Reference Devices

• Nobel Biocare (K133731)
• Nobel Biocare (K020646)
• Nobel Biocare (K102436)
• Biohorizons (K121787)
• Zimmer (K082639)
• MIS (K080162)
• MIS (K103089)
• Biohorizons (K071638)
• Alpha Bio Tec (K063364)
• MSI (K112162)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2017

SpiralTech Superior Dental Implants Daniel Rosenthal Director of Sales and Marketing 875 N. Michigan Ave Suite 3106 Chicago, Illinois 60611

Re: K170372

Trade/Device Name: SpiralTech Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 29, 2017 Received: June 5, 2017

Dear Daniel Rosenthal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170372

Device Name SpiralTech Dental Implant System

#### Indications for Use (Describe)

The Spiraltech 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. Spiraltech implants are intended for single or multiple unit restorations on splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing 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 3.3 implants adjacent to one another.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <div> <span> <span style="font-size:16px"> <b> </b> </span> </span> <span> </span> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) Summary June 17, 2017

#### SpiralTech Dental Implants

Company: SpiralTech Superior Dental Implants

Address: 875 N. Michigan Ave Suite 3106 Chicago, IL 60611

Phone: [phone]

Contact Person: Daniel Rosenthal

Contact email: [e-mail]

Trade Name: SpiralTech Dental Implant System

Common Name: dental implant and abutment system

Classification Name: endosseous dental implant

Regulation Number: 21 CFR 872.3640

Product Code: DZE

Secondary Product Code: NHA

Predicate Device: Nobel Biocare K071370

Reference Devices: Implants – Nobel Biocare K133731 K020646 K102436 Biohorizons K121787 Zimmer K082639 MIS K080162 K103089 Abutments - Biohorizons K071638 Alpha Bio Tec K063364 MSI K112162

#### Indications for Use

The Spiraltech 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. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing 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 incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3 implants adjacent to one another.

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#### Device Description

The SpiralTech implant system is a comprehensive product line that includes implants, corresponding abutments, and closure screws. SpiralTech dental implants are grade 5 titanium (Ti 6Al-4V ELI, conforms to ASTM F136) implants that come in 2 different surface treatments - SLA, and RBM.

SpiralTech dental implants come in five product lines with four based on their thread designs. The ESi has sharp, square, and rounded threads. The Ultimate and Dynamic lines also have sharp threads with the Dynamic having a reverse buttress thread design. The Premium line features square and sharper threads in a more conventional design. The implants have diameters ranging from 3.0 mm, and the lengths from 8mm to 15 mm. ESi, Ultimate, and Dynamic are intended to be used for immediate loading. The fifth implant type is the One Piece which comes with an abutment which cannot be used with low mechanical stability cases.

Abutments are available in various types including straight, shoulder, angulated, ball attachments, multiunit, temporary and healing. All abutments come in both hex and conical connections. Temporary abutments come in PEEK and zirconia. Healing abutments come in titanium alloy and zirconia. Abutments come in titanium alloy and as a titanium base with zirconia abutments and multi-units are titanium alloy. No SpiralTech abutments are intended to be modified.

#### Sizes

The Hex versions of the designs are available in 3.3, 3.5, 4.3, 5.0, and 6.0 with lengths 8, 10, 11, 13, and 15. The conical versions start at a diameter of 3.5 but are otherwise available in the same sizes and lengths with one exception, the Ultimate and ESi designs also come in 3.0 diameter with lengths of 10, 11, 13, and 15.

| Diameter (mm) | Implant Lengths (mm) |
|---------------|-----------------------|
| 3.3mm | 8, 10, 11.5, 13, 15mm |
| 3.5mm | 8, 10, 11.5, 13, 15mm |
| 4.3mm | 8, 10, 11.5, 13, 15mm |
| 5.0mm | 8, 10, 11.5, 13, 15mm |
| 6.0mm | 8, 10, 11.5, 13, 15mm |

Hex version implant sizes:

Conical version implant sizes:

| Diameter (mm) | Implant Lengths (mm) |
|---------------|---------------------------------------------------------|
| 3.0mm | 10, 11.5, 13, 15mm – only for Ultimate and ESi implants |
| 3.5mm | 8, 10, 11.5, 13, 15mm |
| 4.3mm | 8, 10, 11.5, 13, 15mm |
| 5.0mm | 8, 10, 11.5, 13, 15mm |
| 6.0mm | 8, 10, 11.5, 13, 15mm |

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The Solo one piece implant comes in diameters 3.0, 3.3, 3.75, and 4.2. It has lengths of 10, 11, 13 and 15.

The smallest diameter conical versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0° and 15° titanium conical abutment models.

The smallest diameter hex versions for the ESi, Ultimate, Dynamic and Premium implants are only compatible with the 0°, 15° and 25° titanium hex abutment models.

# Non-Clinical Testing

Sterilization validation was conducted for the implants according to the respective standards, ISO 11737-1, ISO 11737-2, ISO 11137-1, ISO 11137-2, and ISO 11137-3 (for gamma radiation validation) and ISO 17665-1 and ISO 17665-2 (for moist heat validation). This testing included USP 85, USP 161 and LAL method testing on the implants. The shelf life for the implants supplied sterile is 5 years based on accelerated testing (ASTM F1980) with one year of real time data (ASTM F1929-12, ASTM F88/F88M).

Several designs of SpiralTech Dental Implants were fatigue tested according to ISO 14801. Justification was provided to show the design tested was the worst case for that connection type. The implants with SLA and RBM surface treatments were evaluated by SEM and EDS for surface analysis.

The temporary abutments are made of PEEK. The implants are Ti6Al4V with either SLA or RBM surface treatment. Abutments are either Ti6AL4V or ZrO2. Chemical characterization of the ZrQ2 was provided. Cytotoxicity (MEM elution) has been provided to demonstrate biocompatibility for all subject devices composed of these identified materials.

## Substantial Equivalence

The widths and lengths of the implants are in the same range as the predicate and reference devices. The materials used for all the devices are commonly used in the predicate and reference devices. As can be seen in the table, the thread designs incorporate types of threads used in the predicate and reference devices. The implant connections types are ones used in several predicate devices as can be seen in the table. The indications for use are the predicate device, except for adding more restrictive placement for the Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants. The surface treatments available are the same types as those used on predicate devices.

The testing done for sterilization validation is the same type of testing done on the predicate and reference devices. Also the predicate and reference devices underwent the same ISO 14801 testing.

See the Substantial Equivalence Tables.

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## Conclusion

The SpiralTech Dental Implants are substantially equivalent to the predicate device based on design including implant connection, materials, surface treatments, dimensions, and testing completed.

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# Substantial Equivalence Table

# Implant Table

| | SpiralTech | NobelActive<br>K071370 and<br>K133731 | NobelReplace<br>K020646 | NobelActive<br>3.0<br>K102436 | Internal<br>Tapered<br>Plus from<br>Biohorizons<br>K121787 | Tapered<br>SwissPlus<br>from<br>Zimmer<br>K082639 | MIS Uno<br>K080162 | MIS<br>Short<br>implants<br>K103089 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------|------------------------------------------------------------|---------------------------------------------------|--------------------|-------------------------------------|
| Material | Ti6Al4V | CP Titanium | Ti6Al4V | CP Titanium | Ti6Al4V | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Diameters | 3.0 – 6.0<br>with the<br>exact sizes<br>varying<br>among the<br>designs. | 3.5, 4.3, 5.0,<br>5.5 | 3.5, 4.3, 5.0,<br>6.0 | 3.0 | 3.8, 4.6, 5.8 | 3.7, 4.8 | 3.0 and<br>3.5 | 4.2, 5.0,<br>6.0 |
| Lengths | 8, 10, 11, 13,<br>15 with not<br>all lengths<br>available for<br>all sizes and<br>designs | 8.5, 10, 11.5 | 10, 13, 16 | 10, 11.5, 13,<br>15 | 7.5, 9, 10.5,<br>12, 15 | 8, 10, 12,<br>14 | 10, 13, 16 | 6.0 |
| Indications<br>for Use | The<br>Spiraltech<br>Dental<br>Implants are<br>endosseous<br>implants<br>intended to<br>be surgically<br>placed in the<br>upper or<br>lower jaw<br>arches to | Nobel<br>Biocare's<br>NobelActive<br>implants are<br>endosseous<br>implants<br>intended to<br>be surgically<br>placed in the<br>bone of the<br>upper or<br>lower jaw | | | | | | |

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| provide<br>support for<br>prosthetic<br>devices,<br>such as an<br>artificial<br>tooth, in<br>order to<br>restore<br>patients<br>esthetics<br>and chewing<br>function.<br>Spiraltech<br>implants are<br>intended for<br>single or<br>multiple unit<br>restorations<br>on splinted<br>or non-<br>splinted<br>applications.<br>The implants<br>ESi Dynamic<br>and Ultimate<br>are intended<br>for<br>immediate<br>loading<br>when good<br>primary<br>stability is<br>achieved | arches to<br>provide<br>support for<br>prosthetic<br>devices, such<br>as an<br>artificial<br>tooth, in<br>order to<br>restore<br>patient<br>esthetics and<br>chewing<br>function.<br>Nobel<br>Biocare's<br>Nobelactive<br>implants are<br>indicated for<br>single or<br>multiple unit<br>restorations<br>in splinted<br>and non-<br>splinted<br>applications.<br>Nobel<br>Biocare's<br>NobelActive<br>implants are<br>intended for<br>immediate<br>loading when<br>good primary | | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| and with | stability is | | | | |
| appropriate | achieved and | | | | |
| occlusive | with | | | | |
| loading. | appropriate | | | | |
| These | occlusal | | | | |
| implants | loading. | | | | |
| [along with | | | | | |
| Premium | | | | | |
| and One | | | | | |
| Piece] can | | | | | |
| also be used | | | | | |
| for loading | | | | | |
| after a | | | | | |
| conventional | | | | | |
| healing | | | | | |
| 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 | | | | | |

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| | incisor in the<br>mandible.<br>Mandibular<br>central and<br>lateral<br>incisors<br>must be<br>splinted if<br>using two or<br>more 3.0<br>and/or 3.3<br>implants<br>adjacent to<br>one another. | | | | | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|---|---|--|
| ESI thread<br>design<br>reference<br>device | | | | | X | |
| Dynamic<br>thread<br>design<br>reference<br>device | | | | X | | |
| Premium<br>thread<br>design<br>reference<br>device | | | X | | | |
| Ultimate<br>thread<br>design<br>reference<br>and<br>predicate | | X | | | | |

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| device | | | | | | | | | |
|-------------------------------------------------------------------------------------|--------------|-------------|--------------------|---------|-----|---------|--------------|-----|--|
| One Piece<br>thread<br>design<br>reference<br>and<br>predicate<br>device | | | | | | X | | | |
| Radiation<br>Sterilization<br>of the<br>Implants | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Validated<br>Steam<br>Sterilization<br>Instructions<br>supplied<br>for<br>abutments | Yes | Yes | Yes | Yes | Yes | Yes | No abutments | Yes | |
| Subject of<br>Fatigue<br>testing<br>meeting<br>ISO 14801 | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Connection<br>interface | hex, conical | hex | conical | hex | hex | octagon | N/A | hex | |
| Surface<br>Treatments<br>Available | SLA, RBM | Acid etched | HA, acid<br>etched | TiUnite | RBM | HA, RBM | SLA | SLA | |

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# Abutment Table

| Abutments | | Hex | Conical<br>NP | Conical RP | Slim<br>Conical |
|----------------------------------------------------------------|-------------------|----------------------------------|----------------------------------|----------------------------------|-----------------|
| Flat Titanium<br>Straight | 3.8<br>(Narrow) | Facial<br>Heights -<br>5,7,9,11 | Facial<br>Heights -<br>5,7,9,11 | Facial<br>Heights –<br>5,7,9,11 | |
| Flat Titanium<br>Straight | 4.5<br>(Standard) | Facial<br>Heights –<br>5,7,9,11 | Facial<br>Heights -<br>5,7,9,11 | Facial<br>Heights -<br>5,7,9,11 | |
| Flat Titanium<br>Straight | 5.5 (Wide) | Facial<br>Heights -<br>5,7,9,11 | | Facial<br>Heights -<br>5,7,9,11 | |
| Flat Titanium<br>Shoulder | 3.8 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3 | |
| Flat Titanium<br>Shoulder | 4.5 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3 | |
| Flat Titanium<br>Shoulder | 5.5 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3 | |
| Anatomic<br>Titanium | 4.5 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | |
| Anatomic<br>Titanium | 5.5 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights –<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | |
| 15 Degree<br>Angulated - | 4.7 | Facial<br>Heights - | Facial<br>Heights – | Facial<br>Heights - | |
| Titanium | | | | | |
| 25 Degree<br>Angulated -<br>Titanium | 5.2 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | |
| 30 Degree<br>Angulated -<br>Titanium | 5.3 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | |
| Flat Titanium<br>Slim | 3.7 | | | Facial<br>Heights -<br>1,2,3 | |
| 15 degree<br>Angulated<br>Titanium slim | 3.7 | | | Facial<br>Heights -<br>1,2,3 | |
| Titanium<br>Multiunit<br>Abutments -<br>Straight | - | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | |
| Titanium<br>Multiunit<br>Abutments -<br>17 Degree<br>angulated | - | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | Facial<br>Heights -<br>1,2,3,4 | |
| Titanium<br>Multiunit<br>Abutments -<br>30 degree<br>angulated | - | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | Facial<br>Heights -<br>1,2,3 | |
| Titanium<br>Healing<br>Abutment | 3.8 | Facial<br>Heights -<br>2,3,4,5,6 | Facial<br>Heights -<br>2,3,4,5,6 | Facial<br>Heights -<br>2,3,4,5,6 | |
| Titanium<br>Healing | 4.5 | Facial<br>Heights - | Facial<br>Heights - | Facial<br>Heights - | |
| Abutment | | | | | |
| Titanium<br>Healing<br>Abutment | 5.5 | Facial Heights -<br>2,3,4,5,6 | Facial Heights -<br>2,3,4,5,6 | Facial Heights -<br>2,3,4,5,6 | |
| Zirconia<br>Anatomic<br>Abutments | 4.5 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | | |
| Zirconia<br>Healing<br>Abutment | 3.8 | Facial Heights -<br>2,3,4,5,6 | Facial Heights -<br>2,3,4,5,6 | Facial Heights -<br>2,3,4,5,6 | |
| Zirconia<br>Healing<br>Abutment | 5.5 | Facial Heights -<br>3,4 | | Facial Heights -<br>3,4 | |
| PEEK<br>Temporary Flat<br>Abutments | Length - 10 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| PEEK<br>Temporary Flat<br>Abutments | Length - 11 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| PEEK<br>Temporary Flat<br>Abutments | Length - 12 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| PEEK<br>Temporary<br>anatomic<br>Abutments | Length - 10 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| PEEK<br>Temporary<br>Anatomic<br>Abutments | Length - 11 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| PEEK<br>Temporary<br>Anatomic<br>Abutments | Length - 12 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | Facial Heights -<br>1,2,3 | |
| Abutments | | | | | |
| Implant<br>Prosthetic<br>Indicator | - | Facial Heights –<br>1,2,3,4,5,6 | Facial Heights –<br>1,2,3,4,5,6 | Facial Heights –<br>1,2,3,4,5,6 | |
| Ball<br>Attachments | - | Facial Heights –<br>1,2,3,4,5,6 | Facial Heights –<br>1,2,3,4,5,6 | Facial Heights –<br>1,2,3,4,5,6 | |

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| | SpiralTech (Internal Hex<br>and Conical<br>Connection) | Biohorizon (Conical<br>Internal Hex) K071638 | Alpha Biotec (Internal<br>Hex Connection)<br>K063364 | MIS (Internal Hex)<br>K112162 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Straight Titanium<br>Abutments | Diameters – 3.8,4.5,5.5<br>Facial Heights - 5,7,9,11 | Laserlok Simple<br>abutments<br>Diameters - 3.8,4.5,5.5<br>Facial Heights - 5,7,9,11 | Titanium Abutments<br>Diameters -3.85,4.5,5.3<br>Facial Heights - 6,7,8,9 | Straight Titanium<br>Abutments<br>Diameters - 3.8,4.5,5.5<br>Facial Heights - 5,7,9,11 |
| Anatomic Titanium<br>abutments | Diameter - 4.5<br>Facial Heights - 1,2,3,4<br>Diameter - 5.5<br>Facial Heights - 1,2,3 | Straight Esthetic<br>connections<br>Diameters –<br>3.0,3.5,4.5,5.7<br>Facial Heights - 1,2,3 | Anatomic Abutments<br>with Emergence Profile<br>Diameter - 4.3<br>Facial Heights - 1.5,2<br>Diameter - 5.5<br>Facial Heights - 2,3 | |
| Shoulder Titanium<br>abutments | Diameter - 3.8<br>Facial Heights - 1,2,3<br>Diameter - 4.5<br>Facial Heights - 1,2,3,4<br>Diameter - 5.5<br>Facial Heights - 1,2,3 | | Straight abutments with<br>various cuff heights<br>Diameter - 3.85<br>Facial Heights -<br>0.5,1.5,2.5<br>Diameter - 4.8<br>Facial Heights - 1,2,3,4<br>Diameter - 5.6<br>Facial Heights - 2,4 | |
| Angulated titanium<br>abutments | 15 Degree - Diameter -<br>4.7 - Heights - 1,2,3<br>25 Degree - Diameter -<br>5.2 - Heights - 1,2,3<br>30 Degree - Diameter -<br>5.3 - Heights - 2,3,4,5 | 15 Degree - Diameter -<br>4.5,5.7 - Heights - 2,3<br>25 Degree - Diameter -<br>5.2 - Heights - 1,2,3<br>30 Degree - Diameter -<br>5.3 - Heights - 2,3,4,5 | Angled Abutments<br>15 Degree - Diameter -<br>4.5,4.8,5.1 - Heights -<br>1,2,3<br>25 Degree - Diameter -<br>4.7, 5.3 - Heights - 1,2,3 | |
| | | | 35 Degree - Diameter -<br>4.65, 5.3 - Heights -<br>1,2,3 | |
| Titanium Healing<br>abutments | Diameter - 3.8<br>Facial Heights -<br>2,3,4,5,6<br>Diameter - 4.5<br>Facial Heights -<br>2,3,4,5,6<br>Diameter - 5.5<br>Facial Heights -<br>2,3,4,5,6 | Titanium Healing<br>abutments<br>Diameter - 3.8<br>Facial Heights - 1,3,5<br>Diameter - 4.7<br>Facial Heights - 1,3,5<br>Diameter - 5.7<br>Facial Heights - 1,3,5 | Titanium Healing<br>abutments<br>Diameter - 3.8<br>Facial Heights - 3,4,5<br>Diameter - 4.5<br>Facial Heights -<br>2,3,4,5,6,7<br>Diameter - 5,<br>5.5,6,7,7.8<br>Facial Heights - 3,5 | Titanium Healing<br>abutments<br>Diameter - 3.8<br>Facial Heights -<br>2,3,4,5,6,7<br>Diameter - 5.5<br>Facial Heights - 3,4,5,6 |
| Zirconia Abutments -<br>Anatomic | Diameter - 4.5<br>Facial Heights - 1,2,3 | | | Straight Anatomic<br>Zirconia<br>Diameter - 4.5<br>Facial Heights - 1,2,3,4 |
| Zirconia Healing<br>abutments | | | | |
| Multi unit abutments | Straight<br>Diameter - 4.7<br>Facial Heights - 1,2,3,4<br>17 Degree<br>Diameter - 5.3<br>Facial Heights -1,2,3<br>30 Degree<br>Diameter - 5.4<br>Facial Heights - 1,2,3 | Multi unit abutments<br>Straight<br>Diameter - 4.5<br>Facial Heights -<br>1,2,3,4,5<br>17 Degree<br>Diameter - 4.5<br>Facial Heights -2.25,3,4<br>30 Degree<br>Diameter - 3.5,4.5 | Straight<br>Diameter - 4.7<br>Facial Heights -<br>1.5,2.5,3,4,5<br>17 Degree<br>Diameter - 5.3<br>Facial Heights -2,3<br>30 Degree<br>Diameter - 5.4<br>Facial Heights - 2,3 | Straight<br>Diameter - 4.7<br>Facial Heights -<br>1,2,3,4,5,6<br>17 Degree<br>Diameter - 5.3<br>Facial Heights -2,3<br>30 Degree<br>Diameter - 5.4<br>Facial Heights - 2,3 |
| | | Facial Heights - 3,4,5 | | |
| PEEK temporary<br>abutments Straight | Diameter - 4.5<br>Facial Heights - 1,2,3 | Temporary PEEK<br>abutments<br>Diameter -<br>3.0,3.5,4.5,5.7<br>Facial Heights - 3 | | |
| PEEK temporary<br>abutments Anatomic | Diameter - 4.5<br>Facial Heights - 1,2,3 | | Temporary PEEK<br>abutments<br>Diameter - 5.4<br>Facial Heights - 1,2,3 | |
| Ball attachments | Heights - 1,2,3,4,5,6 | Ball attachments<br>Diameter - 4.5<br>Facial Heights - 1,3,5 | Titanium Ball<br>attachments<br>Heights - 0.5,2,3,4,5,6 | Titanium Ball<br>attachments<br>Heights - 1,2,3,4,5,6 |

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