(64 days)
No
The summary describes a dental implant system made of titanium with standard components and manufacturing processes. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as an implant system for supporting prosthetic devices, which helps restore chewing function. It is a medical device used for restoring function, not for treating a disease or condition.
No
The Honorst Implant System is designed to support prosthetic devices and restore chewing function, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components made of titanium (fixtures, abutments, and screws) intended for surgical placement. It is a hardware device, not software only.
Based on the provided information, the Honorst Implant System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for supporting prosthetic devices (artificial teeth) and restoring chewing function by being surgically placed in the bone. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the components (fixtures, abutments, screws) and their material (titanium) and how they are surgically placed. This aligns with a medical device used for treatment and support, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Honorst Implant System does not fit this description.
N/A
Intended Use / Indications for 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, 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.
Product codes
DZE, NHA
Device 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 one-body implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 worst-case 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
-
- 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. ।
4
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, | ||
| 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, | ||
| ASTM F67 | 4.0 | 1.5 / 3.0 | |
| Temporary Abutment | Titanium Gr4, | ||
| 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, | ||
| ASTM F136 | 4.3 / 4.8 | 3.0 / 4.0 / 5.0 / 7.0 / 9.0 |
5
| Abutments | Material | Dia. (mm) | Gingival Height |
|---|---|---|---|
| Dual Abutment | Titanium Gr4, | ||
| 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, | ||
| 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.
6
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) | |||
| Number | K202039 | K160536 | K063341 |
| K121995 | |||
| Device Name | Honorst Implant System | CHAORUM Implant System | 3I OSSEOTITE CERTAIN |
| DENTAL IMPLANTS | |||
| TS Fixture System | |||
| Manu-facturer | MEDIMECCA Co., Ltd. | MEDIMECCA Co., Ltd. | IMPLANT INNOVATIONS, INC. |
| OSSTEM Implant Co., Ltd. | |||
| Indications | |||
| for 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. | CHAORUM 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. | |||
| CHAORUM Implant System | |||
| is for single stage and two stage | |||
| surgical procedures. This system is | |||
| intended for delayed loading. | 3i dental implants are intended for | ||
| surgical placement in the upper or | |||
| lower jaw to | |||
| provide a means for prosthetic | |||
| attachment in single tooth | |||
| restorations and in partially or | |||
| fully edentulous spans with multiple | |||
| single teeth, or as a terminal or | |||
| intermediary | |||
| abutment for fixed or removable | |||
| bridgework, and to retain | |||
| overdentures. | |||
| In addition, when a minimum of 4 | |||
| implants, >IOmni in length, are | |||
| placed in the | |||
| mandible and splinted in the anterior | |||
| region, immediate loading is | |||
| indicated. | |||
| The TS Fixture System is designed | |||
| for dental implant surgery, it is | |||
| placed on the maxillary or | |||
| mandibular alveolar bone through a | |||
| surgical procedure, and after | |||
| osseointegration with the alveolar | |||
| bone, it can replace a lost tooth by | |||
| connecting the abutment post. The | |||
| TS Fixture System is indicated for | |||
| use in partially of fully edentulous | |||
| mandibles and maxillae, in support | |||
| of single or multiple-unit restorations | |||
| including; cemented retained, screw | |||
| retained, or overdenture restorations, | |||
| and final or temporary abutment | |||
| support for fixed bridgework. It is | |||
| intended for delayed loading. |
- Fixture
510(k) Submission.
510(k) summary , 4 / 9 page
7
| Design
/ Technological
Characteristics | - Internal Hexagon
connection
- Self-tapping cutting edge
threads | - Internal Hexagon connection - Self-tapping cutting edge threads | - Internal Hexagon connection
- Self-tapping cutting edge threads | - Internal Hexagon connection
- Submerged Fixture
- Tapered body shape and straight
body shape - 4 sided cutting edge with self-
tapping |
|----------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endosseous
Implant
Material | Titanium
(ASTM F67) | Titanium
(ASTM F136, ASTM F67) | Titanium
(ASTM F136, ASTM F67) | Titanium
(ASTM F67) |
| Surface
Treatment | SLA | RBM,
SLA | SLA | SLA |
| Implant
Sterilization
Method | Radiation Sterile | Radiation Sterile | - | Radiation Sterile |
| Implant
Diameters | 3.75-6.0mm | 3.25-6.0mm | 3.25-6.0mm | 3.56.8mm |15.0mm |
| Implant
Lengths | 7.0-13.0mm | 7.3-15.0mm | 7.0-20.0mm | 7.0
8
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 | ||
| 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. | CHAORUM 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 termina | |||
| or intermediate abutment support for | |||
| fixed bridgework. CHAORUM | |||
| Implant System is for single stage | |||
| and two stage surgical procedures. | |||
| This system is intended for delayed | |||
| loading. | |||
| Principle of | |||
| Operation | - Internal Hexagon connection | - Internal Hexagon connection | |
| Dual Abutment | |||
| Design & Size Range | Hex/Non-Hex | ||
| Diameter: 4.0~6.0mm | |||
| Gingival Height: 1.0~5.0mm | |||
| Angle: 0° | Hex/Non-Hex | ||
| Diameter: 3.5~6.5mm | |||
| Gingival Height: 1.0~5.5mm | |||
| Angle: 0° | |||
| Technological | |||
| Characteristics | Screw retained restoration | Screw retained restoration | |
| Material | |||
| 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 | |||
| in terms of intended use and technical characteristics. They are made of the | |||
| Substantial | |||
| Equivalence | |||
| same material. There is a size option change, but the predicate device | |||
| Discussion | |||
| encompasses the size range of the subject device. | |||
| Combi Abutment | |||
| Design & Size Range | Diameter: 4.0~6.0mm | ||
| Gingival Height: 1.0~5.0mm | |||
| Angle: 0° | Diameter: 3.5~6.5mm | ||
| Gingival Height: 1.0~5.5mm | |||
| Angle: 0° | |||
| Technological | |||
| Characteristics | Abutment and screw in one-piece | ||
| structure. | Abutment and screw in one-piece | ||
| structure. | |||
| Material | |||
| Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Combi Abutment is substantially equivalent to the predicate | ||
| devices in terms of intended use and technical characteristics. They are made | |||
| of the same material. There is a size option change, but the predicate device | |||
| encompasses the size range of the subject device. | |||
| Milling Abutment | |||
| Design & Size Range | Hex/Non-Hex | ||
| Diameter: 4.0~6.0mm | |||
| Gingival Height: 1.5~3.0mm | |||
| Angle: 0° | Hex/Non-Hex | ||
| Diameter: 3.5~6.5mm | |||
| Gingival Height: 1.0~3.5mm | |||
| Angle: 0° | |||
| Technological | |||
| Characteristics | Screw retained restoration | Screw retained restoration | |
| Material | |||
| Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Milling Abutment is substantially equivalent to the predicate | ||
| devices in terms of intended use and technical characteristics. They are made | |||
| of the same material. There is a size option change, but the predicate device | |||
| encompasses the size range of the subject device. | |||
| Temporary Abutment | |||
| Design & Size Range | Hex/Non-Hex | ||
| Diameter: 4.0~4.5mm | |||
| Gingival Height: 1.0~3.0mm | Hex/Non-Hex | ||
| Diameter: 3.5~5.5mm | |||
| Gingival Height: 1.0~3.0mm | |||
| Angle: 0° | Angle: 0° | ||
| Technological | |||
| Characteristics | Screw retained restoration | Screw retained restoration | |
| Material | |||
| Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | No | No | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Temporary Abutment is substantially equivalent to the predicate | ||
| devices in terms of intended use and technical characteristics. They are made | |||
| of the same material. There is a size option change, but the predicate device | |||
| encompasses the size range of the subject device. | |||
| Angled Abutment | |||
| Design & Size Range | Hex/Non-Hex | ||
| Diameter: 4.0~6.0mm | |||
| Gingival Height: 2.0, 4.0mm | |||
| Angle : 17° | Hex/Non-Hex | ||
| Diameter: 3.5~6.0mm | |||
| Gingival Height: 1.5~5.0mm | |||
| Angle : 15~25° | |||
| Technological | |||
| Characteristics | Screw retained restoration | Screw retained restoration | |
| Material | |||
| Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Angled Abutment is substantially equivalent to the predicate | ||
| devices in terms of intended use and technical characteristics. They are made | |||
| of the same material. The angle has changed to 17° but it is within the range of | |||
| the unmodified device. Also the location of TiN coating has changed but the | |||
| difference is very minor not affecting substantial equivalence. | |||
| Ball Abutment | |||
| Design & Size Range | Diameter: 3.5mm | ||
| Gingival Height: 1.0~5.0mm | |||
| Angle: 0° | Diameter: 3.5~4.0mm | ||
| Gingival Height: 1.0~5.0mm | |||
| Angle: 0° | |||
| Technological | |||
| Characteristics | Abutment and screw in one-piece | ||
| structure. | Abutment and screw in one-piece | ||
| structure. | |||
| Material | |||
| Composition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Ball Abutment is substantially equivalent to the predicate devices | ||
| in terms of intended use and technical characteristics. They are made of the | |||
| same material. The size and the design are also the same. | |||
| Healing Abutment | |||
| Design & Size Range | Diameter: 4.3~8.3mm | ||
| Gingival Height: 3.0~9.0mm | |||
| Angle: 0° | Diameter: 3.5~8.5mm | ||
| Gingival Height: 0~9.5mm | |||
| Angle: 0° | |||
| Technological | |||
| Characteristics | Abutment and screw in one-piece | ||
| structure. | Abutment and screw in one-piece | ||
| structure. | |||
| Material | |||
| Composition | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | Anodizing | No | |
| Sterile | No | No | |
| Substantial | |||
| Equivalence | |||
| Discussion | The subject Healing Abutment is substantially equivalent to the predicate | ||
| devices in terms of intended use and technical characteristics. They are made | |||
| of the same material. There is a size option change, but the predicate device | |||
| encompasses the size range of the subject device. |
510(k) Submission.
510(k) summary , 6 / 9 page
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510(k) Submission.
510(k) summary , 7 / 9 page
10
510(k) Submission.
510(k) summary , 8 / 9 page
11
9. Conclusion
The new device and the predicate device are substantially equivalent in the areas of technical characteristics, raw material, and design. The new device does not introduce a fundamentally new scientific technology, and the validation activities demonstrate that the subject device is substantially equivalent to the predicate device.