Dentis Dental Implant System

K171027 · Dentis Co., Ltd. · DZE · Sep 6, 2017 · Dental

Device Facts

• Record ID: K171027
• Device Name: Dentis Dental Implant System
• Applicant: Dentis Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Device Story

The Dentis Dental Implant System comprises endosseous dental implants (fixtures) and associated abutments (i-Clean, s-Clean, and e-Clean systems). Fixtures are surgically placed into the upper or lower jaw arches to serve as artificial roots for prosthetic attachments. The system utilizes RBM (Resorbable Blasted Media) surface treatment on fixtures. Implants are placed by dental professionals in clinical settings using either two-stage (with transmucosal healing) or single-stage (immediate loading) surgical protocols. The device provides a stable foundation for single or multiple-unit restorations, including cemented, screw-retained, or overdenture prosthetics. By restoring chewing function, the system benefits patients with tooth loss. The current submission expands the existing product line by adding new fixture designs (Straight, Tapered II, SAVE II) and various abutment sizes, leveraging biocompatibility and performance data from previously cleared Dentis systems.

Clinical Evidence

No clinical testing was performed for this submission. Substantial equivalence is supported by non-clinical bench testing, including LAL endotoxin testing (USP <85>, <161>), biocompatibility (ISO 10993), sterilization validation (ISO 11137, ISO 17665), and shelf-life validation (ISO 11607, ASTM F1980).

Technological Characteristics

Materials: CP Titanium Grade 4, Ti-6Al-4V ELI (Grade 5), PEEK, Acetal, Gold Alloy, Co-Cr-Mo Alloy. Surface: RBM. Connection: Internal/External Hex, Morse taper. Sterilization: Gamma irradiation (fixtures/cover screws), steam sterilization by user (abutments). Connectivity: N/A (mechanical device).

Indications for Use

Indicated for patients requiring single or multiple-unit prosthetic appliance attachment in the upper or lower jaw arches to restore chewing function. Suitable for two-stage surgical processes with transmucosal healing or single-stage processes for immediate loading when primary stability and occlusal loading conditions are met.

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

• Dentis Dental Implant System (K073486)
• OneQ-SL s-Clean Implant System (K142313)
• s-Clean OneQ-SL Narrow Implant System (K161244)

Reference Devices

• OneQ-SL s-Clean Implant System (K153639)
• Dentis Dental Implant System (K150344)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

September 6, 2017

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

Re: K171027

Trade/Device Name: Dentis Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 31, 2017 Received: August 8, 2017

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.

{1}------------------------------------------------

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 devicerelated 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 (DICE) 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 (DICE) 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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K171027

Device Name Dentis Dental Implant System

#### Indications for Use (Describe)

The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange swirl design on the left, followed by the word "DENTIS" in black, bold letters. The swirl design appears to be a stylized representation of a tooth or a dental-related symbol.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

#### 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: Dentis Dental Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant Primary Product Code: DZE Secondary Product Code: NHA Regulation Number: 872.3640 Device Class: Class II Date Prepared: 9/5/2017

#### Description

The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:

#### 1) i-Clean System

#### Fixture

i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture

#### Abutment

i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Dentis. The logo consists of an orange swirl on the left and the word "DENTIS" in black font on the right. The swirl is a gradient of orange, with the darkest shade at the bottom and the lightest shade at the top.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

### 2) s-Clean System

#### Fixture

s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture

#### Abutment

s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment

#### 3) e-Clean System

#### Fixture

e-Clean Tapered Fixture/ e-Clean Tapered II Fixture

#### Abutment

e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment

The surface of the fixture has been treated with RBM (Resorbable Blasted media).

The dimensions of the fixtures are below:

#### <i-Clean Fixtures>

- . i-Clean Tapered Fixture

| Diameter | Length |
|----------|------------------|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 4.3mm | 8, 10, 12, 14 mm |
| Ø 4.7mm | 8, 10, 12, 14 mm |

#### . i-Clean Straight Fixture

| Diameter | Length |
|-----------|-----------------|
| Ø 4.05 mm | 8, 10, 12, 14mm |
| Ø 4.25mm | 8, 10, 12, 14mm |
| Ø 4.75mm | 8, 10, 12, 14mm |

#### ● i-Clean Tapered II Fixture

| Diameter | Length |
|----------|------------------|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1 mm | 8, 10, 12, 14 mm |
| Ø 4.3 mm | 8, 10, 12, 14 mm |
| Ø 4.7 mm | 8, 10, 12, 14 mm |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the word "DENTIS" in a bold, sans-serif font. To the left of the word is an orange graphic. The graphic appears to be a stylized flame or abstract shape, with a gradient from a darker orange at the base to a lighter orange at the tip.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

- i-Clean SAVE Fixture .

| Diameter | Length |
|----------|--------------------|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |

#### i-Clean SAVE II Fixture .

| Diameter | Length |
|----------|-----------------|
| Ø 5.5mm | 7, 8, 10, 12 mm |
| Ø 6.0mm | 7, 8, 10, 12 mm |

#### <s-Clean Fixtures>

- s-Clean Tapered Fixture

| Diameter | Length |
|----------|------------------|
| Ø 3.7 mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 4.3mm | 8, 10, 12, 14 mm |
| Ø 4.8mm | 8, 10, 12, 14 mm |

#### . s-Clean Straight Fixture

| Diameter | Length |
|----------|----------------------|
| Ø 4.1mm | 8, 10, 12, 14, 16 mm |
| Ø 4.3mm | 8, 10, 12, 14, 16 mm |
| Ø 4.75mm | 8, 10, 12, 14, 16 mm |

#### ● s-Clean SAVE Fixture

| Diameter | Length |
|----------|--------------------|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |

#### . s-Clean SAVE II Fixture

| Diameter | Length |
|----------|--------------------|
| Ø 5.5mm | 7, 8, 9, 10, 12 mm |
| Ø 6.0mm | 7, 8, 9, 10, 12 mm |

#### <e-Clean Fixtures>

- . e-Clean Tapered Fixture

| Diameter | Length |
|----------|------------------|
| Ø 3.5mm | 8, 10, 12, 14 mm |
| Ø 4.1mm | 8, 10, 12, 14 mm |
| Ø 5.1mm | 8, 10, 12, 14 mm |

#### e-Clean Tapered II Fixture .

| Diameter | Length |
|----------|------------------|
| Ø3.5mm | 8, 10, 12, 14 mm |
| Ø4.1mm | 8, 10, 12, 14 mm |
| Ø5.1mm | 8, 10, 12, 14 mm |

{6}------------------------------------------------

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : [phone] / Fax : [phone]

The packaging has composed of fixture with cover screw. The fixtures, cover screws and healing abutments are supplied sterile by gamma sterilization. The fixtures are provided as set-packing with the cover screws. The abutments are provided separately and should be sterilized by user before use.

#### Indication for Use

The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

#### Predicate Devices & Comparison

The subject device is substantially equivalent to the following predicate devices:

- . K073486, Dentis Dental Implant System by Dentis Co., Ltd. - Primary predicate
- K142313, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
- K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd. .

#### 1 Fixtures

- a. i-Clean System

| a. | Subject device | Primary Predicate device | Reference Predicate Device | Reference Predicate Device |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Dentis Dental<br>Implant System | Dentis Dental<br>Implant System | OneQ-SL s-Clean<br>Implant System | s-Clean OneQ-SL<br>Narrow Implant<br>System |
| 510(k) number | NA | K073486 | K142313 | K161244 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | The Dentis<br>Dental Implant<br>System is an<br>endosseous<br>dental implant<br>that is indicated<br>for surgical<br>placement in<br>the upper and<br>lower jaw<br>arches, to<br>provide a root<br>form means for<br>single or<br>multiple-units<br>prosthetic<br>appliance | The Dentis Dental<br>Implant System is an<br>endosseous dental<br>implant is indicated<br>for surgical placement<br>in the upper and lower<br>jaw arches, to provide<br>a root form means for<br>single or multiple-<br>units prosthetic<br>appliance attachment<br>to restore a patient's<br>chewing function.<br>Implants can be<br>placed with a<br>conventional two | The OneQ-SL<br>Implant System is<br>indicated for use in<br>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 | The s-Clean OneQ-<br>SL Narrow Implant<br>System (3.0,<br>3.3mm) may be<br>used as an artificial<br>root structure for<br>single tooth<br>replacement of<br>mandibular central<br>and lateral incisors<br>and maxillary<br>lateral incisors.<br>The implants may<br>be restored<br>immediately<br>1) with a temporary<br>prosthesis that is |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the color transitioning from a lighter orange at the top to a darker orange at the bottom.

{8}------------------------------------------------

9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806 - Tel : [phone] /Fax : [phone]

| Gamma sterilized | Yes | Yes | Yes | Yes |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Shelf Life | 8 years | 2 years | 1 years | 8 years |
| Brief Comparison | Similarities: The subject device has equivalent indications for use, material,<br>surface treatment, dimension, sterilization, and shelf life as predicate devices.<br>Differences: New fixtures added to include Straight, Tapered II, and SAVE II<br>designs that have slightly different thread profiles and sizes; new diameter sizes<br>added for Tapered (Ø 4.1, 4.7mm) and SAVE (Ø 5.5, 6.0mm) designs. All<br>fixtures with new co-packaging to include Cover Screw. With different shapes<br>and sizes added, leveraged information from fixtures in predicate (K073486)<br>justified to show worst case by comparing the measurements of proposed fixtures<br>from each system. Therefore, addition of fixtures does not raise any risks and<br>questions. The reference predicates, s-Clean OneQ-SL Narrow Implant System<br>(K161244), supports substantial equivalence of shelf life. | | | |

### b. s-Clean System

| | Subject device | Predicate device | Reference Predicate Device | Reference Predicate Device |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Dentis Dental Implant System | Dentis Dental Implant System | OneQ-SL s-Clean Implant System | s-Clean OneQ-SL Narrow Implant System |
| 510(k) number | NA | K073486 | K153639 | K161244 |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Intended use | The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing | The Dentis Dental Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate | The OneQ-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading | 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 |
| | function. | loading. Immediate | | artificial root |
| | Implants can be | loading is restricted to | | structure for |
| | placed with a | the anterior mandible | | multiple tooth |
| | conventional | based on four splinted | | replacement of |
| | two stage | Interforaminal placed | | mandibular |
| | surgical process | implants. | | incisors, or |
| | with an option | | | 3) for denture |
| | for | | | stabilization using |
| | transmucosal | | | multiple implants |
| | | | | in the anterior |
| | healing or they | | | mandible and<br>maxilla. |
| | can be placed in | | | The implants may |
| | a single stage | | | |
| | surgical process | | | be placed in |
| | for immediate | | | immediate |
| | loading when | | | function when |
| | good primary | | | good primary |
| | stability has | | | stability has been |
| | been achieved | | | achieved and with |
| | and with | | | appropriate occlusal |
| | appropriate | | | loading. |
| | occlusal | | | |
| | loading. | | | |
| | | | | |
| Material | CP Titanium Gr.4 | CP Titanium Gr.4 | CP Titanium Gr.4 | Ti-6Al-4V ELI |
| | Tapered, SAVE, | - Tapered: Internal | | Straight and |
| | Straight, and | Hex connected, | | tapered implant |
| | | Submerged, micro- | • Internal Hex-<br>connected | body |
| | SAVE II | thread design | | 3 sided cutting |
| Design | designs, each<br>Internal Hex<br>connected…