AnyRidge Octa 1 Implant System

K182448 · Megagen Implant Co., Ltd. · DZE · Oct 9, 2019 · Dental

Device Facts

• Record ID: K182448
• Device Name: AnyRidge Octa 1 Implant System
• Applicant: Megagen Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: - Delayed loading. - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

Device Story

AnyRidge Octa 1 Implant System consists of endosseous dental implant fixtures and various abutments (EZ Post, Angled, Milling, Octa, Multi-unit, Meg-Rhein, CCM, Healing, Temporary, Fuse). Fixtures are surgically placed into the alveolar bone to replace missing teeth; abutments connect to fixtures via screws to support prosthetic restorations. Operated by dental professionals in clinical settings. Fixtures are CP Ti Grade 4 with SLA surface treatment; abutments are Ti-6Al-4V ELI or Cobalt Chrome Molybdenum. System provides prosthetic support for chewing function restoration. Benefits include versatility in loading protocols (delayed or immediate) and various abutment options for different clinical needs.

Clinical Evidence

Bench testing only. Includes fatigue testing per ISO 14801, sterilization validation (ISO 11137, ISO 17665-1, 2), shelf-life validation (ASTM F1980), and surface characterization (EDS, roughness, GC/LC, IC). Biocompatibility relies on predicate data. Endotoxin testing limit <0.5 EU/mL per USP 39 <85>.

Technological Characteristics

Materials: CP Ti Grade 4 (fixture), Ti-6Al-4V ELI (ASTM F136-13), Cobalt Chrome Molybdenum (ASTM F1537-11). Surface: SLA (fixture), Anodized (abutments). Connection: Internal Octa. Sterilization: Gamma irradiation or moist heat (autoclave). Form factor: Tapered body fixtures with 0.8mm thread pitch.

Indications for Use

Indicated for partially or fully edentulous individuals requiring prosthetic support for dental restorations (crowns, bridges, overdentures) in maxillary or mandibular arches. Suitable for delayed or immediate loading protocols when primary stability is achieved.

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

• XPEED AnyRidge Internal Implant System (K122231)
• AnyRidge Internal Implant System (K110955)
• AnyOne Internal System (K123988)
• NobelActive Multi Unit Abutment (K072570)
• s-Clean OneQ-SL Narrow Implant System (K161244)
• Healing Cap (K051636)

Reference Devices

• Straumann Bone Level Tapered Implants (K140878)
• Internal Octa Implant System (K170031)
• IBS Implant system (K153350)
• Octa Abutment (K171027)

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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 9, 2019

MegaGen Implant Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620

Re: K182448

Trade/Device Name: AnyRidge Octa 1 Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 26, 2019 Received: September 9, 2019

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 (QS) 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.

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

Enclosure

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# Indications for Use

510(k) Number (if known) K182448

Device Name AnyRidge Octa 1 Implant System

#### Indications for Use (Describe)

The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function situations and with the clinical protocols:

- Delaved loading.
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Larger implants are dedicated for the molar region.

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

(K182448)

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

# Date: Oct 8, 2019

# 1. Applicant / Submitter

MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828

# 2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine CA 92620 Tel: [phone] Fax: [phone] Email: [e-mail]

# 3. Device

- י Trade Name: AnyRidge Octa 1 Implant System
- י Common Name: Endosseous Dental Implant
- י Classification Name: Implant, Endosseous, Root-Form
- Primary Product Code: DZE '
- י Secondary Product Code: NHA
- י Classification regulation: Class II, 21 CFR 872.3640

# 4. Predicate Device:

- Primary Predicate Device: K122231 - XPEED AnyRidge Internal Implant System
- Reference Devices:

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K140878 Straumann Bone Level Tapered Implants K170031 Internal Octa Implant System K153350 IBS Implant system K110955 AnyRidge Internal Implant System K171027 Octa Abutment K072570 NobelActive Multi Unit Abutment K123988 AnyOne Internal System K051636 Healing Cap

#### 5. Description:

The AnyRidge Octa 1 Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.

The abutments are made of Ti-6AI-4V-ELI (ASTM F136-13) except the CCM Abutment. The CCM Abutment is made of Cobalt Chrome Molybdenum (ASTM F1537-11). Also for the Fuse Abutment, the post is covered with provisional restoration that is made of plastic (POM).

The system offers the following components.

| No | Component |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | AnyRidge Octa 1 Fixture<br>Ø 3.60 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 3.70 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 4.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 4.10 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 4.40 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 4.80 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 5.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm<br>Ø 5.50 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm |
| 2 | EZ Post Abutment<br>Ø 4.00 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.85<br>mm<br>Ø 5.00 x 7.85, 8.85, 9.35, 9.85, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35,<br>14.85, 15.35, 16.35 mm<br>Ø 6.00 x 9.35, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35,<br>16.35 mm<br>Ø 7.00 x 9.35, 10.35, 10.85, 11.35, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35,<br>16.35 mm |
| 3 | Angled Abutment (15, 25°)<br>Ø 4.00 x 10.85, 11.85, 12.85, 13.85, 14.85 mm<br>Ø 5.00 x 10.85, 11.85, 12.35, 12.85, 13.35, 13.85, 14.35, 14.85, 15.35, 16.35 mm<br>Ø 6.00 x 12.35, 13.35, 14.35, 15.35, 16.35 mm<br>Ø 7.00 x 12.35, 13.35, 14.35, 15.35, 16.35 mm |
| 4 | Milling Abutment(Only be for Hand Milling with no CAD/CAM)<br>Ø 6.00 x 12.85, 13.85, 14.85, 15.85, 16.85 mm |

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| | Ø 8.00 x 14.35, 15.35, 16.35, 17.35, 18.35 mm |
|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5 | Octa Abutment<br>Ø 3.80 x 7.85, 8.85, 9.85, 10.85, 11.85 mm<br>Ø 4.80 x 9.35, 10.35, 11.35, 12.35, 13.35 mm<br>Ø 5.80 x 10.85, 11.85, 12.85, 13.85, 14.85 mm |
| 6 | Multi-unit Abutment<br>Ø 4.80 x 9.80, 10.80, 11.80, 12.80 mm |
| 7 | Multi-unit Angled Abutment (17, 30°)<br>Ø 4.8 x 5.35, 6.35, 6.85, 7.35, 7.85, 8.85mm |
| 8 | Meg-Rhein Abutment<br>Ø 2.90<br>7 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mm<br>Ø 3.407 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mm |
| 9 | CCM Abutment<br>Ø 3.80 x 14.65, 16.15 mm |
| 10 | Cover Screw<br>Ø 3.00 x 6.60, 7.10 mm<br>Ø 3.70 x 6.60, 7.10 mm<br>Ø 5.00 x 6.60 mm<br>Ø 6.00 x 6.60 mm |
| 11 | Healing Abutment<br>Ø 3.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm<br>Ø 4.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm<br>Ø 5.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm<br>Ø 6.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm |
| 12 | Temporary Abutment<br>Ø 4.00 x 14.85, 15.85 mm<br>Ø 4.50 x 16.35, 17.35 mm<br>Ø 5.00 x 16.35, 17.35 mm |
| 13 | Fuse Abutment<br>Ø 5.40 x 12.05, 13.55 mm |
| 14 | Abutment Screw<br>Ø 2.20 x 7.90 mm |
| 15 | Multi-unit Abutment Screw<br>Ø 2.10 x 7.00 mm |

The following abutment models have anodized surface treatment.

▪ EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fixture Mount.

#### 6. Indication for use:

The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations

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and with the clinical protocols:

- Delayed loading.

Immediate loading when good primary stability is achieved and with – appropriate occlusal loading.

Larger implants are dedicated for the molar region.

#### 7. Basis for Substantial Equivalence

AnyRidge Octa 1 Implant System is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are made of the same material and have similar design. The size range of the predicate device encompasses the size range of the subject device. There are slight differences in design, however, it is very minor not affecting substantial equivalence. There are some verbiage differences in the indications for use statements but it is a difference in language and the indications for use of the two devices are identical.

We have performed the fatigue test to make sure the difference in design does not raise an issue in safety and effectiveness and the test result of the test supported substantial equivalence.

Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.

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| | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 |
|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | K182448 | K122231 | K140878 | K170031 |
| Device Name | AnyRidge Octa 1<br>Implant Fixture | XPEED AnyRidge<br>Internal Implant<br>System | Straumann Bone<br>Level Tapered<br>Implants | Internal Octa Implant<br>System |
| Manufacturer | MegaGen Implant<br>Co., Ltd. | MegaGen Implant<br>Co., Ltd. | Straumann USA, LLC | EBI Inc. |
| Indications for<br>Use Statement | The AnyRidge Octa 1<br>Implant System is<br>intended to be<br>surgically placed in the<br>maxillary or<br>mandibular arches for<br>the purpose of<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous individuals.<br>It is used to restore a<br>patient's chewing<br>function in the<br>following situations<br>and with the clinical<br>protocols:<br>- Delayed loading.<br>- Immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Larger implants are<br>dedicated for the molar<br>region. | The Xpeed AnyRidge<br>Internal Implant<br>System is intended to<br>be surgically placed in<br>the maxillary or<br>mandibular molar<br>areas for the purpose<br>providing prosthetic<br>support for dental<br>restorations (Crown,<br>bridges, and<br>overdentures) in<br>partially or fully<br>edentulous<br>individuals. It is used<br>to restore a patients<br>chewing function.<br>Smaller implants (less<br>than 6.0 mm) are<br>dedicated for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading.<br>Larger implants are<br>dedicated for the<br>molar region and are<br>indicated for delayed<br>loading. | Straumann dental<br>implants are indicated<br>for oral endosteal<br>implantation in the<br>upper and lower jaw<br>and for the functional<br>and esthetic oral<br>rehabilatation of<br>endentulous and<br>partially dentate<br>patients. Straumann<br>dental implants can<br>also be used for<br>immediate or early<br>implantation<br>following extraction<br>or loss of natural<br>teeth. Implants can be<br>placed with<br>immediate function on<br>single-tooth and/or<br>multiple tooth<br>applications when<br>good primary stability<br>is achieved and with<br>appropriate occlusal<br>loading, to restore<br>chewing function. The<br>prosthetic restoration<br>used are single<br>crowns, bridges and<br>partial or full<br>dentures, which are<br>connected to the<br>implants by the<br>corresponding<br>elements (abutments). | The Internal Octa<br>Implant System is<br>intended for<br>placement in the<br>maxillary and/or<br>mandibular arched to<br>support crowns,<br>bridges, or<br>overdentures in<br>edentulous patients.<br>The Internal Octa<br>Implant System is<br>intended for<br>immediate loading<br>when good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading. |
| Appearance | Image: blue dental implant | Image: blue dental implant | Image: gray dental implant | Image: gray dental implant |
| Material | CP Ti Grade 4 | CP Ti Grade 4 | CP Ti Grade 4 | CP Ti Grade 4 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Diameter(Ø) | 3.6, 4.0, 4.4, 4.7, 4.8 mm | 4.0, 4.4, 4.9, 5.4, 5.9 mm | 3.3, 4.1, 4.8mm | 4.1, 4.8mm |
| | 5.0, 5.5mm | 6.4, 6.9, 7.4, 7.9, 8.4mm | 8, 10, 12, 14mm | 7.2~14.2mm |
| Length (mm) | 7.0, 7.7, 9.2, 10.7,<br>12.2, 14.2, 17.2mm | 7.7, 7.9, 9.2, 9.4, 10.7,<br>10.9, 12.2, 12.4,<br>14.20, 14.4, 17.2mm | 8, 10, 12, 14mm | 7.2~14.2mm |
| Surface<br>treatment | Sand-blasted, Large<br>grit, Acid-etched<br>(S.L.A) | Sand-blasted, Large<br>grit, Acid-etched<br>(S.L.A) | Sand-blasted, Large<br>grit, Acid-etched<br>(SLA) | Sand-blasted, Large<br>grit, Acid-etched<br>(S.L.A) |
| Implant-to-<br>abutment<br>connection | Octa | Hex | Narrow CrossFit<br>Regular CrossFit | Octa |
| Feature | - Submerged implant<br>- Tapered body<br>- cutting edge with<br>self tapping<br>- 0.8mm thread pitch | - Submerged implant<br>- Tapered body<br>- No cutting edge with<br>self tapping<br>- 0.8mm thread pitch | - Submerged implant<br>- Tapered body<br>- cutting edge with<br>self-tapping<br>- 0.8mm thread pitch | - Submerged implant<br>- Parallel walled body<br>- cutting edge with<br>self-tapping<br>- Thread pitch :<br>unknown |
| Principle of<br>operation | This product is a<br>tapered body fixture<br>which is inserted in<br>the alveolar bone. It<br>replaces the functions<br>of the missing teeth as<br>a dental implant<br>fixture. | This product is a<br>tapered body fixture<br>which is inserted in<br>the alveolar bone. It<br>replaces the functions<br>of the missing teeth as<br>a dental implant<br>fixture. | - | - |
| Shelf Life | 5 Years | 5 Years | - | 5 Years |
| Substantial Equivalence Discussion | | | | |
| The subject device has the same material, surface treatment, indication for use, and principle of opeartion as the<br>predicate device. | | | | |

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The differences between the subject device and the predicate device is that the subject device has the diameter 3.6mm and cutting edge. The connection type is also different.

The subject device does not include the diameter larger than 5.5mm so the corresponding indication for use of the predicate device for larger implant was excluded. Other than this difference, the IFU statement is the same as the predicate device.

The cutting edge functions as self-tapping by creating a screw path. This difference is covered by the reference device 1 and 2.

The difference in connection type is covered by the reference device 2.

The 3.6mm implant size is covered by the reference device 1.

Despite these differences, the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.

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# EZ Post Abutment

| | Subject Device | Predicate Device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182448 | K110955 |
| Device Name | EZ Post Abutment<br>for AnyRidge Octa 1 System | EZ Post<br>for AnyRidge Internal System |
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for<br>Use Statement | The AnyRidge Octa 1 Implant System is<br>intended to be surgically placed in the<br>maxillary or mandibular arches for the<br>purpose of providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully edentulous<br>individuals. It is used to restore a patient's<br>chewing function in the following situations<br>and with the clinical protocols:<br>- Delayed loading.<br>- Immediate loading when good primary<br>stability is achieved and with appropriate<br>occlusal loading.<br>Larger implants are dedicated for the molar<br>region. | The Xpeed AnyRidge Internal Implant System<br>is intended to be surgically placed in the<br>maxillary or mandibular molar areas for the<br>purpose providing prosthetic support for<br>dental restorations (Crown, bridges, and<br>overdentures) in partially or fully edentulous<br>individuals. It is used to restore a patients<br>chewing function. Smaller implants (less than<br>6.0 mm) are dedicated for immediate loading<br>when good primary stability is achieved and<br>with appropriate occlusal loading. Larger<br>implants are dedicated for the molar region<br>and are indicated for delayed loading. |
| Appearance | Image: EZ Post Abutment | Image: EZ Post…