Honorst Implant System

K202039 · Medimecca Co., Ltd. · DZE · Sep 25, 2020 · Dental

Device Facts

• Record ID: K202039
• Device Name: Honorst Implant System
• Applicant: Medimecca Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Device Story

Honorst Implant System comprises titanium fixtures, abutments, and screws for surgical placement in jaw bone; restores chewing function by supporting prosthetic teeth. Fixtures feature internal hexagon connection and self-tapping threads; SLA surface treatment. Abutments include various types (Dual, Combi, Milling, Temporary, Angled, Ball, Healing) to connect fixtures to prosthetics. Used in clinical dental settings by trained professionals; single or two-stage surgical procedures. Device provides stable foundation for restorations; enables fixed or removable prosthetic attachment. Benefits include restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing performed on worst-case fixture sizes and angled abutments. Biocompatibility, sterilization, and shelf-life testing were not repeated as materials, surface treatments, and packaging remain identical to the predicate (K160536).

Technological Characteristics

Materials: Titanium Grade 4 (ASTM F67) and Ti 6Al4V ELI (ASTM F136). Design: Threaded, root-form endosseous implants with internal hexagon connection. Surface: SLA treatment; TiN coating on specific abutments; anodizing on healing abutments. Sterilization: Radiation. Form factor: Various diameters (3.75-8.3mm) and lengths (7.0-13.0mm).

Indications for Use

Indicated for partially or fully edentulous patients requiring dental restoration in the mandible or maxilla. Supports single or multiple-unit restorations (cemented, screw-retained, or overdenture) and fixed bridgework. Contraindications: Not for immediate loading.

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

• CHAORUM Implant System (K160536)

Reference Devices

• 3I OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341)
• TS Fixture System (K121995)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2020

Medimecca Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620

Re: K202039

Trade/Device Name: Honorst Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 22, 2020 Received: August 27, 2020

### Dear Priscilla Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

Honorst Implant System

Indications for Use (Describe)

Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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### 510(k) Summary (K202039)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 09/25/2020

## 1. Submitter/Applicant

Medimecca Co., Ltd. Daeryung Techno Town 3-Cha 104, 105, 109, 110 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul, Republic of Korea, 08505

## 2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: [phone] Fax: [phone] Email: juhee.c(@lkconsultinggroup.com

- 3. Device
- . Trade Name: Honorst Implant System
- Common Name: Dental Implant System ●
- Classification: Class II
- Classification regulation: 21 CFR 872.3640 ●
- Product Code: DZE, NHA ●

#### Predicate Devices: 4.

Primary Predicate Device: CHAORUM Implant System (K160536) by MEDIMECCA Co., Ltd.

Reference Devices:

- 31 OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341) by IMPLANT -INNOVATIONS, INC.
- TS Fixture System (K121995) by OSSTEM Implant Co., Ltd. ।

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#### న్. Description:

Honorst Implant System are devices made of titanium 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, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.

## 5.1. Fixtures - SLA (Titanium Gr4, ASTM F67)

### 5.2. Abutments

## · NP (Narrow Platform) Connection Type Abutments

| Abutments | Material | Dia. (mm) | Gingival Height |
|----------------------|----------------------------|-----------------|-----------------------------|
| Dual Abutment | Titanium Gr4,<br>ASTM F67 | 4.0 / 4.6 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Combi Abutment | | 4.0 / 4.6 / 4.8 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Milling Abutment | Titanium Gr4,<br>ASTM F67 | 4.0 | 1.5 / 3.0 |
| Temporary Abutment | Titanium Gr4,<br>ASTM F67 | 4.0 | 1.0 / 3.0 |
| Angled Abutment(17°) | | 4.0 / 4.5 | 2.0 / 4.0 |
| Ball Abutment | | 3.5 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Abutments | Material | Dia. (mm) | Height |
| Healing Abutment | Ti 6Al4V ELI,<br>ASTM F136 | 4.3 / 4.8 | 3.0 / 4.0 / 5.0 / 7.0 / 9.0 |

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| Abutments | Material | Dia. (mm) | Gingival Height |
|----------------------|---------------------------|-----------------------------|-----------------------------|
| Dual Abutment | Titanium Gr4,<br>ASTM F67 | 4.6 / 5.0 / 6.0 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Combi Abutment | | 4.0 / 4.6 / 4.8 / 5.0 / 6.0 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Milling Abutment | | 4.0 / 5.0 / 6.0 | 1.5 / 3.0 |
| Temporary Abutment | | 4.5 | 1.0 / 3.0 |
| Angled Abutment(17°) | | 4.5 / 5.0 / 6.0 | 2.0 / 4.0 |
| Ball Abutment | | 3.5 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |

· RP (Regular Platform) Connection Type Abutments

| Abutments | Material | Dia. (mm) | Height |
|------------------|----------------------------|-----------------------------------|-----------------------------|
| Healing Abutment | Ti 6Al4V ELI,<br>ASTM F136 | 4.3 / 4.8 / 5.3 / 6.3 / 7.3 / 8.3 | 3.0 / 4.0 / 5.0 / 7.0 / 9.0 |

5.3. Cover Screw (Ti 6A14V ELI, ASTM F136)

3.05mm Dia. x 5.25mm (L) 3.60mm Dia. x 5.88mm (L)

#### Indication for use: 6.

Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

#### 7. Performance Data

The verification/validation testing activities were conducted on the subject device for the modifications made. The activities include identifying reference devices for external fixture design changes and a worst-case analysis of the subject device and primary predicate for fixture size and angled abutment modifications. The worstcase analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing. Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests.

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#### 8. Substantial Equivalence

The Honors Implant System has the same intentified predicate devices. They are similar in findamental soientific technology in that they are all threaded, root form implans constructed of transmiss. The subject and predicate fixtures are both bone-level implants that share similar body shape design such as straight walled neck and tapen . The modifications were made after the 510k clearance including fixture exterior design and size, but we found reference devices which encompasses the size range of the subject device with similar design.

The subject abutments are very similar to the medications are very minor which does not result in an issue to question substantial equivalence.

| Item | Subject Device | Primary Predicate Device | Reference Predicate Devices |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | K202039 | K160536 | K063341<br>K121995 |
| Device Name | Honorst Implant System | CHAORUM Implant System | 3I OSSEOTITE CERTAIN<br>DENTAL IMPLANTS<br>TS Fixture System |
| Manu-facturer | MEDIMECCA Co., Ltd. | MEDIMECCA Co., Ltd. | IMPLANT INNOVATIONS, INC.<br>OSSTEM Implant Co., Ltd. |
| Indications<br>for Use | Honorst Implant System is<br>intended for use in partially<br>or fully edentulous mandibles<br>and maxilla, in<br>support of single of multiple-<br>unit restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal or<br>intermediate abutment<br>support for fixed bridgework.<br>Honorst Implant System<br>is for single stage and two<br>stage surgical procedures.<br>This system is intended for<br>delayed loading. | CHAORUM Implant System is<br>intended for use in partially or fully<br>edentulous mandibles and maxilla, in<br>support of single of multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and<br>terminal or intermediate abutment<br>support for fixed bridgework.<br>CHAORUM Implant System<br>is for single stage and two stage<br>surgical procedures. This system is<br>intended for delayed loading. | 3i dental implants are intended for<br>surgical placement in the upper or<br>lower jaw to<br>provide a means for prosthetic<br>attachment in single tooth<br>restorations and in partially or<br>fully edentulous spans with multiple<br>single teeth, or as a terminal or<br>intermediary<br>abutment for fixed or removable<br>bridgework, and to retain<br>overdentures.<br>In addition, when a minimum of 4<br>implants, >IOmni in length, are<br>placed in the<br>mandible and splinted in the anterior<br>region, immediate loading is<br>indicated.<br>The TS Fixture System is designed<br>for dental implant surgery, it is<br>placed on the maxillary or<br>mandibular alveolar bone through a<br>surgical procedure, and after<br>osseointegration with the alveolar<br>bone, it can replace a lost tooth by<br>connecting the abutment post. The<br>TS Fixture System is indicated for<br>use in partially of fully edentulous<br>mandibles and maxillae, in support<br>of single or multiple-unit restorations<br>including; cemented retained, screw<br>retained, or overdenture restorations,<br>and final or temporary abutment<br>support for fixed bridgework. It is<br>intended for delayed loading. |

1. Fixture

510(k) Submission.

510(k) summary , 4 / 9 page

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| Design<br>/ Technological<br>Characteristics | - Internal Hexagon<br>connection<br>- Self-tapping cutting edge<br>threads | - Internal Hexagon connection<br>- Self-tapping cutting edge threads | - Internal Hexagon connection<br>- Self-tapping cutting edge threads | - Internal Hexagon connection<br>- Submerged Fixture<br>- Tapered body shape and straight<br>body shape<br>- 4 sided cutting edge with self-<br>tapping |
|----------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endosseous<br>Implant<br>Material | Titanium<br>(ASTM F67) | Titanium<br>(ASTM F136, ASTM F67) | Titanium<br>(ASTM F136, ASTM F67) | Titanium<br>(ASTM F67) |
| Surface<br>Treatment | SLA | RBM,<br>SLA | SLA | SLA |
| Implant<br>Sterilization<br>Method | Radiation Sterile | Radiation Sterile | - | Radiation Sterile |
| Implant<br>Diameters | 3.75-6.0mm | 3.25-6.0mm | 3.25-6.0mm | 3.5~6.8mm |
| Implant<br>Lengths | 7.0-13.0mm | 7.3-15.0mm | 7.0-20.0mm | 7.0~15.0mm |

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#### 2. Abutments

| | Subject Device | Predicate Device | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(K) Number | K202039 | K160536 | |
| Device Name | Honorst Implant System | Chaorum Dental Implant System | |
| Manufacturer | Medimecca Co., Ltd. | Medimecca Co., Ltd. | |
| Indications for Use | Honorst Implant System is intended<br>for use in partially or fully edentulous<br>mandibles and maxilla, in support of<br>single of multiple-unit restorations<br>including; cemented retained, screw<br>retained, or overdenture restorations,<br>and terminal or intermediate<br>abutment support for fixed<br>bridgework. Honorst Implant System<br>is for single stage and two stage<br>surgical procedures. This system is<br>intended for delayed loading. | CHAORUM Implant System is<br>intended for use in partially or fully<br>edentulous mandibles and maxilla, in<br>support of single of multiple-unit<br>restorations including; cemented<br>retained, screw retained, or<br>overdenture restorations, and termina<br>or intermediate abutment support for<br>fixed bridgework. CHAORUM<br>Implant System is for single stage<br>and two stage surgical procedures.<br>This system is intended for delayed<br>loading. | |
| Principle of<br>Operation | - Internal Hexagon connection | - Internal Hexagon connection | |
| | Dual Abutment | | |
| Design & Size Range | Hex/Non-Hex<br>Diameter: 4.0~6.0mm<br>Gingival Height: 1.0~5.0mm<br>Angle: 0° | Hex/Non-Hex<br>Diameter: 3.5~6.5mm<br>Gingival Height: 1.0~5.5mm<br>Angle: 0° | |
| Technological<br>Characteristics | Screw retained restoration | Screw retained restoration | |
| Material<br>Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| The subject Dual Abutment is substantially equivalent to the predicate devices<br>in terms of intended use and technical characteristics. They are made of the<br>Substantial<br>Equivalence<br>same material. There is a size option change, but the predicate device<br>Discussion<br>encompasses the size range of the subject device. | | | |
| Combi Abutment | | | |
| Design & Size Range | Diameter: 4.0~6.0mm<br>Gingival Height: 1.0~5.0mm<br>Angle: 0° | Diameter: 3.5~6.5mm<br>Gingival Height: 1.0~5.5mm<br>Angle: 0° | |
| Technological<br>Characteristics | Abutment and screw in one-piece<br>structure. | Abutment and screw in one-piece<br>structure. | |
| Material<br>Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial<br>Equivalence<br>Discussion | The subject Combi Abutment is substantially equivalent to the predicate<br>devices in terms of intended use and technical characteristics. They are made<br>of the same material. There is a size option change, but the predicate device<br>encompasses the size range of the subject device. | | |
| Milling Abutment | | | |
| Design & Size Range | Hex/Non-Hex<br>Diameter: 4.0~6.0mm<br>Gingival Height: 1.5~3.0mm<br>Angle: 0° | Hex/Non-Hex<br>Diameter: 3.5~6.5mm<br>Gingival Height: 1.0~3.5mm<br>Angle: 0° | |
| Technological<br>Characteristics | Screw retained restoration | Screw retained restoration | |
| Material<br>Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial<br>Equivalence<br>Discussion | The subject Milling Abutment is substantially equivalent to the predicate<br>devices in terms of intended use and technical characteristics. They are made<br>of the same material. There is a size option change, but the predicate device<br>encompasses the size range of the subject device. | | |
| Temporary Abutment | | | |
| Design & Size Range | Hex/Non-Hex<br>Diameter: 4.0~4.5mm<br>Gingival Height: 1.0~3.0mm | Hex/Non-Hex<br>Diameter: 3.5~5.5mm<br>Gingival Height: 1.0~3.0mm | |
| | Angle: 0° | Angle: 0° | |
| Technological<br>Characteristics | Screw retained restoration | Screw retained restoration | |
| Material<br>Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | No | No | |
| Sterile | No | No | |
| Substantial<br>Equivalence<br>Discussion | The subject Temporary Abutment is substantially equivalent to the predicate<br>devices in terms of intended use and technical characteristics. They are made<br>of the same material. There is a size option change, but the predicate device<br>encompasses the size range of the subject device. | | |
| | Angled Abutment | | |
| Design & Size Range | Hex/Non-Hex<br>Diameter: 4.0~6.0mm<br>Gingival Height: 2.0, 4.0mm<br>Angle : 17° | Hex/Non-Hex<br>Diameter: 3.5~6.0mm<br>Gingival Height: 1.5~5.0mm<br>Angle : 15~25° | |
| Technological<br>Characteristics | Screw retained restoration | Screw retained restoration | |
| Material<br>Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile…