s-Clean OneQ-SL Narrow Implant System

K161244 · Dentis Co., Ltd. · DZE · Dec 7, 2016 · Dental

Device Facts

• Record ID: K161244
• Device Name: s-Clean OneQ-SL Narrow Implant System
• Applicant: Dentis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Dec 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

Device Story

Endosseous screw-type dental implant system; replaces missing teeth in narrow alveolar ridges or limited horizontal spaces. System includes fixture, cover screw, and various abutments. Fixture features straight/tapered body, 3-sided cutting edge, internal double hex connection, and SLA surface treatment. Used by dentists in clinical settings for single or multiple tooth replacement. Fixtures placed in jaw bone to support prostheses or dentures. Immediate loading permitted with good primary stability and appropriate occlusal loading. Benefits include restoration of masticatory function and denture stabilization in patients with limited bone anatomy.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993), fatigue testing (ISO 14801), endotoxin testing (USP <85>), and sterilization validation (ISO 11137, ISO 17665).

Technological Characteristics

Materials: Ti-6Al-4V ELI (fixture, abutments), Titanium Grade 4 (temporary/healing abutments), Acetal (healing cap), Co-Cr-Mo alloy (CCM abutment), Gold. Design: Bone-level, internal double hex connection, SLA surface. Dimensions: 3.0/3.3mm diameter; 10-14mm length. Sterilization: Gamma (fixture/cover screw), end-user steam (abutments).

Indications for Use

Indicated for single tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors; multiple tooth replacement of mandibular incisors (splinted); and denture stabilization in anterior mandible/maxilla. For use in patients requiring endosseous dental implants.

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

• BioHorizons Laser-Lok 3.0 Implant System (K093321)
• Paltop Narrow Implant (K130462)
• Dentis Dental Implant System (K150344)
• Dentis HAPTITE Implant system (K111364)

Reference Devices

• Dentis Dental Implant System (K073486)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a single, abstract figure.

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

December 7, 2016

Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K161244

Trade/Device Name: s-Clean OneO-SL Narrow Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2016 Received: November 7, 2016

Dear April Lee:

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 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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 yours,

# Michael J. Ryan -S

for Tina Kiang, Ph.D.

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) K161244

Device Name

s-Clean OneQ-SL Narrow Implant System

#### Indications for Use (Describe)

The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1) with a temporary prosthesis that is not in functional occlusion.

2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or

3) for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(K) Summary

#### Submitter

Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu. 42718 South Korea Phone: [phone] Fax: [phone]

# Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: [e-mail] Phone: [phone] Fax: [phone]

# Device Information

Trade Name: s-Clean OneQ-SL Narrow Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE, NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 11/29/2016

# Indication for Use

The s-Clean OneO-SL Narrow Implant System (3.0, 3.3mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

- 1) with a temporary prosthesis that is not in functional occlusion,
- 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- 3) for denture stabilization using multiple implants in the anterior mandible and maxilla.

The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

#### Device Description

The s-Clean OneQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal double hexagonal connection, intended for single use. The s-Clean OneQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.

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# Fixture

This fixture design has straight and tapered implant body, 3 sided cutting edge of bottom, internal double hex connection and bone level implant. The Fixture diameters are 3.0 and 3.3 mm and the lengths are 10, 12 and 14mm.

This product is a dental implant which is placed in the maxillary and mandibular bone to support and maintain upper prostheses or denture. Fixture, the lower part of the main body, is made of Ti-6AI-4V ELI for Narrow type, and SLA (Sand-blasted, Large grit, Acid-etched surface) surface treated. Fixture and cover screw are provided sterile.

# Abutment

The various abutments in this system include s-clean sole narrow abutment, healing cap, s-clean narrow temporary abutment, s-clean narrow O-ring abutment, s-clean narrow healing abutment, s-clean narrow gold UCLA abutment, and s-clean narrow CCM Abutment.

| Item | Description | Dimension | Materials |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------------|
| s-Clean Sole Abutment<br>(Narrow) | upper structure used to produce a dental<br>prosthesis bridge for 2~3 or more teeth.. | Ø 4.0 mm (D) x 9.4,<br>10.4, 10.9, 11.9, 12.4,<br>12.9, 13.4, 14.4, 14.9<br>and 15.9 mm (L) | Ti-6Al-4V ELI |
| Healing Cap | connected sole abutment after connection<br>to sole abutment and contact to gingiva<br>duration 15 days less to protect to tongue | Ø 4.6 mm (D) x 6, 7.5<br>and 9 mm (L) | Acetal |
| s-Clean Temporary<br>Abutment (Narrow) | Arbitrarily shaped upper structure used to<br>restore masticatory movement<br>temporarily by using prosthesis made<br>according to patient's condition | Ø 4.0 mm (D) x 12.5<br>and 13 mm (L) | Titanium Grade 4 |
| s-Clean O-Ring<br>Abutment (Narrow) | Ball type upper structure connects with<br>the top of implant fixture to connect with<br>over denture | Ø 3.5 mm (D) x 10 and<br>12 mm (L) | Ti-6Al-4V ELI |
| s-Clean Healing<br>Abutment (Narrow) | Can be made emergence profile on<br>gingiva for next connecting abutment and<br>be used period 15 days from<br>secondsurgery normally | Ø 4.0 mm (D) x 7.9,<br>8.4, 8.9, 9.4, 9.9, 10.4,<br>10.9 and 11.4 mm (L) | Titanium Grade 4 |
| s-Clean Gold UCLA<br>Abutment (Narrow) | Make castable abutment and is screw<br>retained type | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L) | Gold |
| s-Clean CCM Abutment<br>(Narrow) | Make castable abutment and is screw<br>retained type | Ø 4.0 mm (D) x 14.5<br>and 15 mm (L) | Co-Cr-Mo Alloy |
| s-Clean Abutment<br>Screw | Connection body to connect abutment to<br>fixture | Ø 2.03 mm (D) x 9 mm<br>(L) | Ti-6Al-4V ELI |

The Healing Abutments are provided sterile and other abutments are provided non-sterile. The abutments should be sterilized before use (End user sterilization).

The temporary abutments, CCM abutments and UCLA abutments are not intended to be cast at angulation or placed to provide angular correction.

# Principle of Operation

This product is a dental implant to implant in the jaw to maintain support for partial or full prosthetic restorations teeth or dentures when the loss of teeth as the fixture dental implant, the body (substructure) made titanium and was treated SLA surface.

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# K161244

#### Predicate Devices & Comparison

# 1) Fixtures

- K093321, BioHorizons Laser-Lok 3.0 Implant System
- K130462, Paltop Narrow Implant ●
- K150344, Dentis Dental Implant System .
- K111364, Dentis HAPTITE Implant system

| | Subject device | Primary Predicate | Reference Predicates | | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | s-Clean OneQ-SL Narrow<br>Implant System | BioHorizons Laser-Lok<br>3.0 Implant System | Paltop Narrow Implant | Dentis Dental Implant<br>System | Dentis HAPTITE<br>Implant system |
| 510(k) number | K161244 | K093321 | K130462 | K150344 | K111364 |
| Manufacturer | Dentis Co., Ltd. | BioHorizons Implant<br>Systems, Inc | Paltop Advanced<br>Dental Solutions, Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | CP Titanium Grade 4 | CP Titanium Grade 4 |
| Design | Image: s-Clean OneQ-SL Narrow Implant System | Image: BioHorizons Laser-Lok 3.0 Implant System | Image: Paltop Narrow Implant | Image: Dentis Dental Implant System | Image: Dentis HAPTITE Implant system |
| Design and<br>technological<br>features | Straight and tapered implant<br>body, 3 sided cutting edge of<br>bottom, internal double hex<br>connection and bone level<br>design. | Straight and tapered<br>implant body, Laser-Lok<br>collar, Parallel wall,<br>Internal hex connection<br>and bone level design. | Straight and tapered<br>implant body, 3 sided<br>cutting edge of bottom,<br>internal hex connection<br>and bone level design. | Tapered implant body, 4<br>sided cutting edge of<br>bottom, internal hex<br>connection and bone<br>level design. | Tapered implant body,<br>4 sided cutting edge of<br>bottom, internal hex<br>connection and bone<br>level design. |
| Fixture<br>diameter(Ø) | 3.0, 3.3 mm | 3.0mm | 3.25 mm | 3.7, 4.1, 4.3, 4.8mm | 3.7, 4.1, 4.3, 4.8, 5.5,<br>6.0, 6.5, and 7.0mm |
| Fixture length | 10 ,12, 14 mm | 10.5, 12, 15mm | 10,11.5,13,16 mm | 7, 8, 10 ,12, 14 mm | 7, 8, 9, 10 ,12, 14 and<br>16mm |
| Indication for use | The s-Clean OneQ-SL Narrow<br>Implant System (3.0, 3.3mm)<br>may be used as an artificial<br>root structure for single tooth<br>replacement of mandibular<br>central and lateral incisors and<br>maxillary lateral incisors.<br>The implants may be restored<br>immediately<br>1) with a temporary prosthesis<br>that is not in functional<br>occlusion,<br>2) when splinted together as<br>an artificial root structure for<br>multiple tooth replacement of<br>mandibular incisors, or<br>3) for denture stabilization<br>using multiple implants in the<br>anterior mandible and maxilla.<br>The implants may be placed in<br>immediate function when<br>good primary stability has<br>been achieved and with<br>appropriate occlusal loading. | BioHorizons Laser-Lok<br>3.0 Implants may be used<br>as an artificial root<br>structure for single tooth<br>replacement of<br>mandibular central and<br>lateral incisors and<br>maxillary lateral incisors.<br>The implants may be<br>restored immediately<br>1) with a temporary<br>prosthesis that is not in<br>functional occlusion,<br>2) when splinted together<br>as an artificial root<br>structure for multiple<br>tooth replacement of<br>mandibular incisors, or<br>3) for denture<br>stabilization using<br>multiple implants in the<br>anterior mandible and<br>maxilla.<br>The implants may be<br>placed in immediate<br>function when good<br>primary stability has been<br>achieved and with<br>appropriate occlusal<br>loading. | The Peltop Narrow<br>Implant is indicated for<br>use in surgical and<br>restorative applications<br>for placement in the<br>mandibular central,<br>lateral incisor and<br>maxillary lateral<br>incisor regions of<br>partially edentulous<br>jaws where the<br>horizontal space is<br>limited by the adjacent<br>teeth and roots, to<br>provide support for<br>prosthetic devices,<br>such as artificial teeth,<br>in order to restore the<br>patient's chewing<br>function. The Paltop<br>Narrow Implant is<br>indicated also for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. | The Dentis Dental<br>Implant System is an<br>endosseous dental<br>implant is indicated for<br>surgical placement in<br>the upper and lower jaw<br>arches, to provide a root<br>form means for single or<br>multiple-units prosthetic<br>appliance attachment to<br>restore a patient's<br>chewing function.<br>Implants can be placed<br>with a conventional two<br>stage surgical process<br>with an option for<br>transmucosal healing or<br>they can be placed in a<br>single stage surgical<br>process for immediate<br>loading. Immediate<br>loading is restricted to<br>the anterior mandible<br>based on four splinted<br>interforminal placed<br>implants. | The Dentis Implant<br>System is indicated for<br>use in partially or fully<br>edentulous mandibles<br>and maxillae, in<br>support of single or<br>multiple-unit<br>restorations including;<br>cemented retained,<br>screw retained, or<br>overdenture<br>restorations, and<br>terminal or<br>intermediate abutment<br>support for fixed<br>bridgework. This<br>system is dedicated for<br>one and two stage<br>surgical procedures<br>and not dedicated for<br>immediate loading.<br>This system is intended<br>for delayed loading. |
| Surface treatment | SLA | RBM | SLA | RBM | HA Coating |
| Principle of | Conventional procedure | Conventional procedure | Conventional | Conventional procedure | Conventional |

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| Operation | procedure | procedure | | | |
|-----------------------------------------|----------------------------------------------------------------------|---------------------------------------|---------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------|
| Anatomical Site | Oral cavity<br>mandibles and maxillae | Oral cavity<br>mandibles and maxillae | Oral cavity<br>mandibles and maxillae | Oral cavity<br>mandibles and maxillae | Oral cavity<br>mandibles and maxillae |
| Gamma sterilized | Yes | Yes | Yes | Yes | Yes |
| Abutment | Straight only | Straight and angled | Straight and angled<br>(20°) | Straight and angled<br>(30°) | Straight and<br>angled(25°) |
| Material<br>Composition of<br>Abutments | CP Titanium Grade 4,<br>Ti-6Al-4V ELI,<br>CCM Alloy,<br>Acetal, Gold | Titanium Alloy | Titanium Alloy | CP Titanium Grade 4<br>Ti-6Al-4V ELI,<br>CCM Alloy, Acetal | CP Titanium Grade 3<br>and 4<br>Ti-6Al-4V ELI,<br>PEEK, Gold, Acetal |
| Surface Treatment<br>of Abutments | None | None | None | None | None |
| Product Code | DZE, NHA | DZE | DZE, NHA | DZE, NHA | DZE, NHA |

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# 2) Abutments

- K150344, Dentis Dental Implant System
- K111364, Dentis HAPTITE Implant system
- K073486, Dentis Dental Implant System

# Sole Abutment

| K number | K161244 (Subject) | K150344 | K111364 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | s-Clean Sole Abutment (Narrow) | - | s-Clean Sole Abutment |
| Intended Use | The s-Clean OneQ-SL Narrow Implant System (3.0,<br>3.3mm) may be used as an artificial root structure for<br>single tooth replacement of mandibular central and<br>lateral incisors and maxillary lateral incisors.<br>The implants may be restored immediately<br>1) with a temporary prosthesis that is not in functional<br>occlusion,<br>2) when splinted together as an artificial root structure<br>for multiple tooth replacement of mandibular incisors, or<br>3) for denture stabilization using multiple implants in<br>the anterior mandible and maxilla.<br>The implants may be placed in immediate function when<br>good primary stability has been achieved and with<br>appropriate occlusal loading. | The Dentis Dental Implant System is an<br>endosseous dental implant is indicated for<br>surgical placement in the upper and lower<br>jaw arches, to provide a root form means<br>for single or multiple-units prosthetic<br>appliance attachment to restore a patient's<br>chewing function. Implants can be placed<br>with a conventional two stage surgical<br>process with an option for transmucosal<br>healing or they can be placed in a single<br>stage surgical process for immediate<br>loading. Immediate<br>loading is restricted to the anterior<br>mandible based on four splinted<br>interforminal placed implants. | The HAPTITE coating Implant<br>System is indicated for use in partially<br>or fully edentulous mandibles and<br>maxillae, in support of single or<br>multiple-unit restorations including;<br>cemented retained, screw retained, or<br>overdenture restorations, and terminal<br>or intermediate abutment support for<br>fixed bridgework. This system is<br>dedicated for one and two stage<br>surgical procedures and not dedicated<br>for immediate loading. This system is<br>intended for delayed loading. |
| Materials | Ti-6Al-4V ELI / Non coating | - | Ti-6Al-4V ELI / Non coating |
| Dimension | Ø 4.0 mm (D) x 9.4, 10.4, 10.9, 11.9, 12.4, 12.9, 13.4,<br>14.4, 14.9, 15.9 mm (L) | - | Ø 4.5, 5.5, 6.5 mm (D) x 12.5, 13,<br>13.5, 14, 15, 16, 17mm (L)<br>Ø 4.8, 6.0 mm(D) x 13.3, 14.3, 15.3,<br>16.3, 17.3 mm(L) |
| Healing Cap | | | |
| Product Name | Healing Cap | MU Healing Cap | Healing Cap |
| Materials | Acetal / Non coating | Ti-6Al-4V ELI / Non coating | Acetal / Non coating |
| Dimension | Ø 4.6 mm (D) x 6, 7.5, 9 mm (L) | Ø 5.4 mm (D) x 5 mm (L) | Ø 5.1, 5.8, 6.3, 6.8 mm (D) x 6.5 mm<br>(L) |

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| Temporary Abutment | | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…