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K Number
K182448
Device Name
AnyRidge Octa 1 Implant System
Manufacturer
MegaGen Implant Co., Ltd.
Date Cleared
2019-10-09

(397 days)

Product Code
DZENHA
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 various components including the AnyRidge Octa 1 Fixture, EZ Post Abutment, Angled Abutment, Milling Abutment, Octa Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, Meg-Rhein Abutment, CCM Abutment, Cover Screw, Healing Abutment, Temporary Abutment, Fuse Abutment, Abutment Screw, and Multi-unit Abutment Screw, in various sizes.
More Information

K122231

K140878, K170031, K153350, K110955, K171027, K072570, K123988, K051636

No
The device description and performance studies focus on the mechanical and material properties of the dental implant system, with no mention of AI or ML.

No
The device is a dental implant system used for prosthetic support, which restores chewing function rather than treating a disease or condition.

No

The device description clearly states its purpose is for "providing prosthetic support for dental restorations" and "to restore a patient's chewing function" by being surgically placed. This indicates a therapeutic or restorative function, not a diagnostic one.

No

The device description clearly states it is a dental implant system made of physical materials (CP Ti Grade 4, Ti-6AI-4V-ELI, Cobalt Chrome Molybdenum, plastic) and includes various hardware components (fixtures, abutments, screws, etc.).

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is surgically placed in the body to provide prosthetic support for dental restorations. This is a surgical implant used for structural support and restoration of function.
  • Device Description: The description details the materials and components of a dental implant system, including fixtures, abutments, and screws. These are all physical components designed to be implanted in the jawbone.
  • Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
  • Performance Studies: The performance studies focus on sterilization, shelf life, surface characteristics, fatigue strength, and biocompatibility – all relevant to a surgically implanted device, not an IVD.

IVD devices are used outside the body to examine specimens and provide diagnostic information. This device is placed inside the body for a therapeutic and restorative purpose.

N/A

Intended Use / Indications 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 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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device 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.

1 AnyRidge Octa 1 Fixture
Ø 3.60 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 3.70 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 4.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 4.10 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 4.40 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 4.80 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 5.00 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
Ø 5.50 x 7.00, 7.70, 9.20, 10.70, 12.20, 14.20, 17.20 mm
2 EZ Post Abutment
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
mm
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,
14.85, 15.35, 16.35 mm
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,
16.35 mm
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,
16.35 mm
3 Angled Abutment (15, 25°)
Ø 4.00 x 10.85, 11.85, 12.85, 13.85, 14.85 mm
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
Ø 6.00 x 12.35, 13.35, 14.35, 15.35, 16.35 mm
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)
Ø 6.00 x 12.85, 13.85, 14.85, 15.85, 16.85 mm
Ø 8.00 x 14.35, 15.35, 16.35, 17.35, 18.35 mm
5 Octa Abutment
Ø 3.80 x 7.85, 8.85, 9.85, 10.85, 11.85 mm
Ø 4.80 x 9.35, 10.35, 11.35, 12.35, 13.35 mm
Ø 5.80 x 10.85, 11.85, 12.85, 13.85, 14.85 mm
6 Multi-unit Abutment
Ø 4.80 x 9.80, 10.80, 11.80, 12.80 mm
7 Multi-unit Angled Abutment (17, 30°)
Ø 4.8 x 5.35, 6.35, 6.85, 7.35, 7.85, 8.85mm
8 Meg-Rhein Abutment
Ø 2.90
7 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mm
Ø 3.407 x 8.30, 8.80, 9.80, 10.80, 11.80, 12.80, 13.80 mm
9 CCM Abutment
Ø 3.80 x 14.65, 16.15 mm
10 Cover Screw
Ø 3.00 x 6.60, 7.10 mm
Ø 3.70 x 6.60, 7.10 mm
Ø 5.00 x 6.60 mm
Ø 6.00 x 6.60 mm
11 Healing Abutment
Ø 3.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm
Ø 4.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm
Ø 5.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm
Ø 6.20 x 8.60, 9.60, 10.60, 11.60, 12.60, 13.60, 14.60, 15.60 mm
12 Temporary Abutment
Ø 4.00 x 14.85, 15.85 mm
Ø 4.50 x 16.35, 17.35 mm
Ø 5.00 x 16.35, 17.35 mm
13 Fuse Abutment
Ø 5.40 x 12.05, 13.55 mm
14 Abutment Screw
Ø 2.20 x 7.90 mm
15 Multi-unit Abutment Screw
Ø 2.10 x 7.00 mm

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular arches

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)

Non-Clinical Testing:

  • Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10th).
  • The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
  • The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analvsis.
  • The fatigue tests were performed on the subject devices in accordance with ISO 14801. The worst case scenarios were chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device.
  • The fixture has the same material as the predicate device (K122231), and the abutments including the Fuse Abutment have the same material as the predicate device (K123988). The CCM Abutment also has the same material as the predicate device (K123988) made by our company. The biocompatibility of the predicate final products was evaluated under the previous 510K submissions.
  • The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 .

Conclusion: Based on the similarities, we conclude that the AnyRidge Octa 1 Implant System is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122231 - XPEED AnyRidge Internal Implant System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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 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.

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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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3

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: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

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:

4

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.

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

5

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

6

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.

7

Subject DevicePredicate DeviceReference Device 1Reference Device 2
510(k)
NumberK182448K122231K140878K170031
Device NameAnyRidge Octa 1
Implant FixtureXPEED AnyRidge
Internal Implant
SystemStraumann Bone
Level Tapered
ImplantsInternal Octa Implant
System
ManufacturerMegaGen Implant
Co., Ltd.MegaGen Implant
Co., Ltd.Straumann USA, LLCEBI Inc.
Indications for
Use StatementThe 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. | The Xpeed AnyRidge
    Internal Implant
    System is intended to
    be surgically placed in
    the maxillary or
    mandibular molar
    areas for the purpose
    providing prosthetic
    support for dental
    restorations (Crown,
    bridges, and
    overdentures) in
    partially or fully
    edentulous
    individuals. It is used
    to restore a patients
    chewing function.
    Smaller implants (less
    than 6.0 mm) are
    dedicated for
    immediate loading
    when good primary
    stability is achieved
    and with appropriate
    occlusal loading.
    Larger implants are
    dedicated for the
    molar region and are
    indicated for delayed
    loading. | Straumann dental
    implants are indicated
    for oral endosteal
    implantation in the
    upper and lower jaw
    and for the functional
    and esthetic oral
    rehabilatation of
    endentulous and
    partially dentate
    patients. Straumann
    dental implants can
    also be used for
    immediate or early
    implantation
    following extraction
    or loss of natural
    teeth. Implants can be
    placed with
    immediate function on
    single-tooth and/or
    multiple tooth
    applications when
    good primary stability
    is achieved and with
    appropriate occlusal
    loading, to restore
    chewing function. The
    prosthetic restoration
    used are single
    crowns, bridges and
    partial or full
    dentures, which are
    connected to the
    implants by the
    corresponding
    elements (abutments). | The Internal Octa
    Implant System is
    intended for
    placement in the
    maxillary and/or
    mandibular arched to
    support crowns,
    bridges, or
    overdentures in
    edentulous patients.
    The Internal Octa
    Implant System is
    intended for
    immediate loading
    when good primary
    stability is achieved
    and with appropriate
    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 | 7.214.2mm |
    | Length (mm) | 7.0, 7.7, 9.2, 10.7,
    12.2, 14.2, 17.2mm | 7.7, 7.9, 9.2, 9.4, 10.7,
    10.9, 12.2, 12.4,
    14.20, 14.4, 17.2mm | 8, 10, 12, 14mm | 7.2    14.2mm |
    | Surface
    treatment | Sand-blasted, Large
    grit, Acid-etched
    (S.L.A) | Sand-blasted, Large
    grit, Acid-etched
    (S.L.A) | Sand-blasted, Large
    grit, Acid-etched
    (SLA) | Sand-blasted, Large
    grit, Acid-etched
    (S.L.A) |
    | Implant-to-
    abutment
    connection | Octa | Hex | Narrow CrossFit
    Regular CrossFit | Octa |
    | Feature | - Submerged implant
  • Tapered body
  • cutting edge with
    self tapping
  • 0.8mm thread pitch | - Submerged implant
  • Tapered body
  • No cutting edge with
    self tapping
  • 0.8mm thread pitch | - Submerged implant
  • Tapered body
  • cutting edge with
    self-tapping
  • 0.8mm thread pitch | - Submerged implant
  • Parallel walled body
  • cutting edge with
    self-tapping
  • Thread pitch :
    unknown |
    | Principle of
    operation | This product is a
    tapered body fixture
    which is inserted in
    the alveolar bone. It
    replaces the functions
    of the missing teeth as
    a dental implant
    fixture. | This product is a
    tapered body fixture
    which is inserted in
    the alveolar bone. It
    replaces the functions
    of the missing teeth as
    a dental implant
    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
    predicate device. | | | | |

8

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.

9

EZ Post Abutment

Subject DevicePredicate Device
510(k) NumberK182448K110955
Device NameEZ Post Abutment
for AnyRidge Octa 1 SystemEZ Post
for AnyRidge Internal System
ManufacturerMegaGen Implant Co., Ltd.MegaGen Implant Co., Ltd.
Indications for
Use StatementThe 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. | The Xpeed AnyRidge Internal Implant System
    is intended to be surgically placed in the
    maxillary or mandibular molar areas for the
    purpose providing prosthetic support for
    dental restorations (Crown, bridges, and
    overdentures) in partially or fully edentulous
    individuals. It is used to restore a patients
    chewing function. Smaller implants (less than
    6.0 mm) are dedicated for immediate loading
    when good primary stability is achieved and
    with appropriate occlusal loading. Larger
    implants are dedicated for the molar region
    and are indicated for delayed loading. |
    | Appearance | Image: EZ Post Abutment | Image: EZ Post |
    | Diameter | 4.0, 5.0, 6.0, 7.0mm | 4.0, 5.0, 6.0, 7.0mm |
    | Post Height | 4, 5.5, 7 mm | 5.5, 7mm |
    | Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.8, 2.8, 3.8, 4.8mm |
    | Connection
    Interface | Octa, non-octa | Hex, non-hex |
    | Surface
    treatment | Anodizing | Anodizing |
    | Sterility | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) |
    | Angulation | 0° | 0° |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
    | Principle of
    operation | This product is a superstructure which is
    connects with the fixtures using the Abutment
    Screw. It replaces the functions of the missing
    teeth as a dental abutment. | This product is a superstructure which is
    connects with the fixtures using the Abutment
    Screw. It replaces the functions of the missing
    teeth as a dental abutment. |
    | Substantial Equivalence Discussion | | |
    | The subject device has the same intended use, material, surface treatment, and design as the predicate device.
    The diameter range of the subject device is same as the predicate device, yet the subject device has slightly
    wider range of post height and gingival height. This wider range is to meet each patient needs and does not raise
    an issue in performance or safety since the size difference is very minor.
    The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. | | |

10

Milling Abutment

Subject DevicePredicate Device
510(k) NumberK182448K110955
Device NameMilling Abutment
for AnyRidge Octa 1 SystemMilling Abutment
for AnyRidge Internal System
ManufacturerMegaGen Implant Co., Ltd.MegaGen Implant Co., Ltd.
Indications for
Use StatementThe 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. | The Xpeed AnyRidge Internal Implant
    System is intended to be surgically placed in
    the maxillary or mandibular molar areas for
    the purpose providing prosthetic support for
    dental restorations (Crown, bridges, and
    overdentures) in partially or fully edentulous
    individuals. It is used to restore a patients
    chewing function. Smaller implants (less
    than 6.0 mm) are dedicated for immediate
    loading when good primary stability is
    achieved and with appropriate occlusal
    loading. Larger implants are dedicated for
    the molar region and are indicated for
    delayed loading. |
    | Appearance | Image: Milling Abutment | Image: Milling Abutment |
    | Diameter | 6.0, 8.0mm | 4.0, 5.0, 6.0, 7.0mm |
    | Post Height | 9.0mm | 9.2mm |
    | Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.6, 2.6, 3.6, 4.6mm |
    | Connection
    Interface | Octa, non-octa | Hex, non-hex |
    | Surface treatment | Anodizing | Anodizing |
    | Sterility | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal
    sterilization via moist heat(autoclave) |
    | Angulation | 0° | 0° |
    | Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
    | Principle of
    operation | This product is a superstructure which is
    connects with the fixtures using the Abutment
    Screw. It replaces the functions of the missing
    teeth as a dental abutment. | This product is a superstructure which is
    connects with the fixtures using the
    Abutment Screw. It replaces the functions of
    the missing teeth as a dental abutment. |
    | Substantial Equivalence Discussion | | |
    | The subject device has the same intended use, material, surface treatment, and design as the predicate device.
    The size range of the subject device is slightly different from the predicate device. This wider range is to meet
    each patient needs and does not raise an issue in performance or safety since the size difference is very minor.
    The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. | | |

Octa Abutment

Subject DeviceReference Device 1Reference Device 2
510(k) NumberK182448K110955K171027
Device NameOcta Abutment
For AnyRidge Octa 1 SystemOcta Abutment
for AnyRidge Internal SystemOcta Abutment
For Dental Implant System
ManufacturerMegaGen Implant Co., Ltd.MegaGen Implant Co., Ltd.Dentis Co., Ltd.

11

The AnyRidge Octa 1 ImplantThe Xpeed AnyRidge InternalThe Dentis Dental Implant
Indications for
Use StatementThe 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. | The Xpeed AnyRidge Internal
    Implant System is intended to
    be surgically placed in the
    maxillary or mandibular
    molar areas for the purpose
    providing prosthetic support
    for dental restorations
    (Crown, bridges, and
    overdentures) in partially or
    fully edentulous individuals. It
    is used to restore a patients
    chewing function. Smaller
    implants (less than 6.0 mm)
    are dedicated for immediate
    loading when good primary
    stability is achieved and with
    appropriate occlusal loading.
    Larger implants are dedicated
    for the molar region and are
    indicated for delayed loading. | 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. |
    | Appearance | Image: AnyRidge Octa 1 Implant appearance | Image: Xpeed AnyRidge Internal Implant appearance | Image: Dentis Dental Implant appearance |
    | Diameter | 3.8mm | 4.8mm | 3.5, 4.3mm |
    | Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1, 2, 3, 4, 5mm | Unknown |
    | Connection
    Interface | Internal Conical connection | Internal Conical connection | Internal Conical connection |
    | Surface
    treatment | Color anodization | Color anodization | Machined |
    | Sterility | Non-sterile; intended for
    terminal sterilization via
    moist heat(autoclave) | Non-sterile; intended for
    terminal sterilization via
    moist heat(autoclave) | Non-sterile; intended for
    terminal sterilization via
    moist heat(autoclave) |
    | Angulation | 0° | 0° | 0° |
    | Material | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
    | Principle of
    operation | This product is a
    superstructure which is
    connects with the fixtures
    using the Abutment Screw. It
    replaces the functions of the
    missing teeth as a dental
    abutment. | This product is a
    superstructure which is
    connects with the fixtures
    using the Abutment Screw. It
    replaces the functions of the
    missing teeth as a dental
    abutment. | This product is a
    superstructure which is
    connects with the fixtures
    using the Abutment Screw. It
    replaces the functions of the
    missing teeth as a dental
    abutment. |

The subject device has the same intended use, material, surface treatment, connection interface, and design as the predicate device.

The diameter of the subject device is covered by the reference device 2, yet the subject device has slightly wider range of gingival height. This wider range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor.

12

Multi-unit Abutment

Subject DevicePredicate Device 1Predicate Device 2
510(k)
NumberK182448K072570K123988
Device NameMulti-unit Abutment
for AnyRidge Octa 1 SystemNobelActive Multi Unit
AbutmentMulti-unit Abutment
for AnyOne Internal System
ManufacturerMegaGen Implant Co., Ltd.NOBEL BIOCARE ABMegaGen Implant Co., Ltd.
Indications for
Use StatementThe 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. | NobelActive Multi Unit
    Abutment is a
    pre-manufactured prosthetic
    component directly connected
    to the endosseous dental
    implant and is intended for use
    as an aid in prosthetic
    rehabilitation. | The Xpeed AnyRidge Internal
    Implant System is intended to
    be surgically placed in the
    maxillary or mandibular molar
    areas for the purpose providing
    prosthetic support for dental
    restorations (Crown, bridges,
    and overdentures) in partially
    or fully edentulous individuals.
    It is used to restore a patients
    chewing function. Smaller
    implants (less than 6.0 mm)
    are dedicated for immediate
    loading when good primary
    stability is achieved and with
    appropriate occlusal loading.
    Larger implants are
    dedicated for the molar region
    and are indicated for delayed
    loading. |
    | Appearance | Image: Abutment | Image: Abutment | Image: Abutment |
    | Diameter | 4.8mm | 4.8mm | 5.0mm |
    | Gingival
    Height | 1.3, 2.3, 3.3, 4.3mm | 1.5, 2.5, 3.5, 4.5mm | 1.8, 2.8, 3.8, 4.8mm |
    | Connection
    Interface | Internal Conical connection | Internal Conical connection | Hex, non-hex |
    | Surface
    treatment | Color anodization | Machined | Color anodization |
    | Sterility | Non-sterile; intended for
    terminal sterilization via moist
    heat(autoclave) | Non-sterile; intended for
    terminal sterilization via moist
    heat(autoclave) | Non-sterile; intended for
    terminal sterilization via moist
    heat(autoclave) |
    | Angulation | 0° | 0° | 0° |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | Ti-6A1-4V ELI |
    | Principle of
    operation | Multi-unit Abutment is a pre-
    manufactured prosthetic
    component directly connected
    to the endosseous dental
    implant and is intended for use
    as an aid in prosthetic
    rehabilitation. | NobelActive Multi Unit
    Abutment is a pre-
    manufactured prosthetic
    component directly connected
    to the endosseous dental
    implant and is intended for use
    as an aid in prosthetic
    rehabilitation. | Multi-unit Abutment is a pre-
    manufactured prosthetic
    component directly connected
    to the endosseous dental
    implant and is intended for use
    as an aid in prosthetic
    rehabilitation. |
    | Substantial Equivalence Discussion | | | |
    | | Subject Device | Predicate Device | |
    | 510(k)
    Number | K182448 | K123988 | |
    | Device Name | Meg-Rhein Abutment
    for AnyRidge Octa 1 System | Meg-Rhein Abutment
    for AnyOne Internal System | |
    | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
    | Indications for
    Use Statement | 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. | The AnyOne™ Internal Implant System is
    intended to be surgically placed in the
    maxillary or mandibular molar areas for the
    purpose 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. Smaller implants (less than
    6.0 mm) are dedicated for immediate loading
    when good primary stability is achieved and
    with appropriate oclusal loading. Larger
    implants are
    dedicated for the molar region and are
    indicated for delayed loading. | |
    | Appearance | Image: Subject Device Appearance | Image: Predicate Device Appearance | |
    | Head Diameter | 2.5mm | 2.5mm | |
    | Head Height | 1.7mm | 1.7mm | |
    | Connection
    Interface | Internal Conical connection | Internal Conical connection | |
    | Surface
    treatment | Machined | Machined | |
    | Sterility | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | |
    | Angulation | 0° | 0° | |
    | Principle of
    operation | Meg-Rhein Abutment is designed as an
    endosseous dental implant retentive
    component used to retain a complete or partial
    denture. The Meg-Rhein Abutment is screwed
    into an endosseous implant in the mandible or
    maxilla. | Meg-Rhein Abutment is designed as an
    endosseous dental implant retentive
    component used to retain a complete or partial
    denture. The Meg-Rhein Abutment is screwed
    into an endosseous implant in the mandible or
    maxilla. | |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, size, material, surface treatment, connection interface, and design as
    the predicate devices. | | | |
    | | Subject Device | Predicate Device | Reference Device |
    | 510(k)
    Number | K182448 | K161244 | K153350 |
    | Device Name | CCM Abutment
    for AnyRidge Octa 1 System | CCM Abutment
    For s-Clean OneQ-SL Narrow
    Implant System | IBS Implant system |
    | Manufacturer | MegaGen Implant Co., Ltd. | Dentis Co.,Ltd | Innobiosurg Co.,Ltd |
    | Indications for
    Use Statement | 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. | The s-Clean OneQSL Narrow
    Implant System (3.0, 3.3mm)
    may be used as an artificial
    root structure for single tooth
    replacement of mandibular
    central and lateral incisors
    and maxillary lateral incisors.
    The implants may be restored
    Immediately
  1. with a temporary prosthesis
    that is not in functional
    occlusion,
  2. when splinted together as an
    artificial root structure for
    multiple tooth replacement of
    mandibular incisors, or
  3. for denture stabilization
    using multiple implants in
    the anterior mandible and
    maxilla.
    The implants may be placed in
    immediate function when good
    primary stability has been
    achieved and with appropriate
    occlusal loading. | The CCM Abutment System is
    intended to replace missing
    teeth to restore chewing
    function. The CCM Abutment
    System can be placed in
    support of single or
    multipleunit restorations
    including;cement retained,
    screw retained, and terminal or
    immediate abutment support
    for fixed bridgework. This
    system is for one or two stage
    surgical procedures. This
    system is intended for delayed
    loading. |
    | Appearance | Image: Abutment | Image: Abutment | Image: Abutment |
    | Diameter | 3.8mm | 4.0mm | 3.5, 4, 4.5, 5, 5.5mm |
    | Length | 14.65, 16.15 | 14.5, 15mm | 14, 15, 16, 17mm |
    | Connection
    Interface | Octa, non-octa | Hex, non-hex | Hex, non-hex |
    | Angulation | 0° | 0° | 0° |
    | Principle of
    operation | a screw retained restoration
    type of abutment using a
    screw to fix a prosthesis | a screw retained restoration
    type of abutment using a
    screw to fix a prosthesis | a screw retained restoration
    type of abutment using a
    screw to fix a prosthesis |
    | Material | Cobalt Chrome Molybdenum | Cobalt Chrome Molybdenum | Titanium Alloy Poly Diacetate |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, and design as the predicate devices. | | | |
    | | Subject Device | Predicate Device 1 | Predicate Device 2 |
    | 510(k)
    Number | K182448 | K110955 | K051636 |
    | Device Name | Healing Abutment
    for AnyRidge Octa 1 System | Healing Abutment
    for AnyRidge Internal System | Healing Cap |
    | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | Altatec |
    | Indications for
    Use Statement | 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. | The AnyRidge Internal
    Implant System is intended to
    be surgically placed in the
    maxillary or mandibular molar
    areas for the purpose providing
    prosthetic support for dental
    restorations (Crown, bridges,
    and overdentures) in partially
    or fully edentulous individuals.
    It is used to restore a patients
    chewing function. Smaller
    implants (less than 6.0 mm)
    are dedicated for immediate
    loading when good primary
    stability is achieved and with
    appropriate occlusal loading.
    Larger implants are dedicated
    for the molar region and are
    indicated for delayed loading. | CAMLOG Healing Caps
    (Cylindrical, wide body,
    Bottleneck) displace the
    gingiva from the space above
    the CAMLOG implant or bar
    abutment during the
    CAMLOG implant or bar
    abutment during the
    CAMLOG implant healing
    time and serve for proper
    gingiva shaping. |
    | Appearance | Image: Healing abutment | Image: Healing abutment | Image: Healing cap |
    | Diameter | 3.2, 4.2, 5.2, 6.2mm | 4.2, 5.2, 6.2, 7.2, 8.0, 10.0mm | 3.3, 3.8, 4.3, 5, 6mm |
    | Gingival
    Height | 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5,
    9.5mm | 3.5, 4.5, 5.5, 6.5,7.5mm | 2, 4, 6mm |
    | Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
    | Connection
    Interface | Internal Conical connection
    Internal | Internal Conical connection | Internal Conical connection |
    | Surface
    treatment | Color Anodization | Machined | Machined |
    | Principle of
    operation | The Healing Abutment is
    fastened into the female screw
    of dental implant and support
    the gingival shaping. | The Healing Abutment is
    fastened into the female screw
    of dental implant and support
    the gingival shaping. | Unknown |
    | Material | Ti-6A1-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, connection interface, and design as the predicate devices.
    The subject device has slightly wider range of size to meet each patient needs and does not raise an issue in
    performance or safety since the size difference is very minor.
    The other difference is in surface treatment but we already presented multiple predicate devices for anodizing in the
    other component comparison charts. | | | |
    | | Subject Device | Primary Predicate Device | |
    | 510(k) Number | K182448 | K110955 | |
    | Device Name | Temporary Abutment
    for AnyRidge Octa 1 System | Temporary Abutment
    for AnyRidge Internal System | |
    | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
    | Indications for
    Use Statement | 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. | The AnyRidge Internal Implant System is
    intended to be surgically placed in the
    maxillary or mandibular molar areas for the
    purpose providing prosthetic support for
    dental restorations (Crown, bridges, and
    overdentures) in partially or fully edentulous
    individuals. It is used to restore a patients
    chewing function. Smaller implants (less than
    6.0 mm) are dedicated for immediate loading
    when good primary stability is achieved and
    with appropriate occlusal loading. Larger
    implants are dedicated for the molar region
    and are indicated for delayed loading. | |
    | Appearance | Image: abutment | Image: abutment | |
    | Diameter | 4.0, 5.0mm | 4.0mm | |
    | Post Height | 10mm | 10mm | |
    | Gingival Height | 2.0, 3.0mm | 2.0mm | |
    | Sterilization | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | |
    | Connection
    Interface | Octa, non-octa | He, non-hex | |
    | Surface
    treatment | Color Anodization | Machined | |
    | Angulation | 0° | 0° | |
    | Principle of | Temporary Abutment is used in conjunction | Temporary Abutment is used in conjunction | |
    | operation | with fixture to provide support for provisional
    restoration. | with fixture to provide support for provisional
    restoration. | |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, and design as the predicate devices. | | | |
    | The subject device has slightly wider range of size to meet each patient needs and does not raise an issue in
    performance or safety since the size difference is very minor.
    The other difference is in surface treatment but we already presented multiple predicate devices for anodizing in
    the other component comparison charts. | | | |
    | | Subject Device | Primary Predicate Device | |
    | 510(k) Number | K182448 | K123988 | |
    | Device Name | Fuse Abutment
    for AnyRidge Octa 1 System | Fuse Abutment
    for AnyOne Internal System | |
    | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
    | Indications for
    Use Statement | 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. | The AnyOne Internal Implant System is
    intended to be surgically placed in the
    maxillary or mandibular molar areas for the
    purpose providing prosthetic support for
    dental restorations (Crown, bridges, and
    overdentures) in partially or fully edentulous
    individuals. It is used to restore a patients
    chewing function. Smaller implants (less than
    6.0 mm) are dedicated for immediate loading
    when good primary stability is achieved and
    with appropriate occlusal loading. Larger
    implants are dedicated for the molar region
    and are indicated for delayed loading. | |
    | Appearance | Image: Abutment | Image: Abutment | |
    | Diameter | 5.4mm | 5.3mm | |
    | Post Height | 5.5, 7.0mm | 5.5, 7.0mm | |
    | Gingival Height | 4.0mm | 4.0mm | |
    | Sterilization | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | |
    | Connection
    Interface | Octa, non-octa | He, non-hex | |
    | Angulation | 0° | 0° | |
    | Principle of
    operation | Fuse Abutment is used in conjunction with
    fixture to provide support for provisional
    restoration. | Fuse Abutment is used in conjunction with
    fixture to provide support for provisional
    restoration. | |
    | Material | Ti-6A1-4V ELI, POM | Ti-6A1-4V ELI, POM | |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, and similar design as the predicate devices. | | | |
    | The subject device has slightly wider diameter than the predicate device but the difference is very minor. | | | |
    | The connection interface is also different but both features of Octa and Hex provides anti-rotational feature. | | | |
    | | Subject Device | Primary Predicate Device | |
    | 510(k) Number | K182448 | K110955 | |
    | | Angled Abutment | Angled Abutment | |
    | Device Name | for AnyRidge Octa 1 System | for AnyRidge Internal System | |
    | Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. | |
    | Indications for
    Use Statement | 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 impalnts are dedicated for the molar
    region. | The AnyRidge Internal Implant System is
    intended to be surgically placed in the
    maxillary or mandibular molar areas for the
    purpose providing prosthetic support for
    dental restorations (Crown, bridges, and
    overdentures) in partially or fully edentulous
    individuals. It is used to restore a patients
    chewing function. Smaller implants (less than
    6.0 mm) are dedicated for immediate loading
    when good primary stability is achieved and
    with appropriate occlusal loading. Larger
    implants are dedicated for the molar region
    and are indicated for delayed loading. | |
    | Appearance | Image: Angled Abutment | Image: Angled Abutment | |
    | Diameter | 4.0, 5.0, 6.0, 7.0mm | 3.85, 4.2, 5.0, 6.0mm | |
    | Post Height | 7.0mm | 7.0mm | |
    | Gingival Height | 0.8, 1.8, 2.8, 3.8, 4.8mm | 1.8, 2.8, 3.8, 4.8mm | |
    | Connection
    Interface | Octa, non-octa | Hex, non-hex | |
    | Surface
    treatment | Machined, Color anodization | Color anodization | |
    | Sterility | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | |
    | Angulation | 15°, 25° | 15°, 25° | |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
    | Principle of
    operation | This product is a superstructure which is
    connects with the fixtures using the Abutment
    Screw. It replaces the functions of the missing
    teeth as a dental abutment. | This product is a superstructure which is
    connects with the fixtures using the Abutment
    Screw. It replaces the functions of the missing
    teeth as a dental abutment. | |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, and design as the predicate devices.
    The subject device has slightly wider range of size to meet each patient needs and does not raise an issue in
    performance or safety since the size difference is very minor.
    The connection interface is also different but both features of Octa and Hex provides anti-rotational feature.
    Despite these differences, the test result of fatigue test supported that the subject device is substantially equivalent
    to the predicate device. | | | |
    | | Subject Device | Primary Predicate Device | |
    | 510(k) Number | K182448 | K072570 | |
    | Device Name | Multi-unit Angled Abutment
    for AnyRidge Octa 1 System | Nobel Active Multi Unit Abutment | |
    | Manufacturer | MegaGen Implant Co., Ltd. | Nobel BioCare | |
    | Indications for
    Use Statement | 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 impalnts are dedicated for the molar
    region. | NobelActive Multi Unit Abutment is a pre-
    manufactured prosthetic component directly
    connected to the endosseous dental implant
    and is intended for use as an aid in prosthetic
    rehabilitation. | |
    | Appearance | Image: Multi-unit Angled Abutment for AnyRidge Octa 1 System | Image: Nobel Active Multi Unit Abutment | |
    | Diameter | 4.8mm | 4.8mm | |
    | Gingival Height | 2.3, 3.3, 4.3mm | 1.5, 2.5, 3.5, 4.5mm | |
    | Connection
    Interface | Octa, non-octa | Hex | |
    | Surface
    treatment | Machined | Machined | |
    | Sterility | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | Non-sterile; intended for terminal sterilization
    via moist heat(autoclave) | |
    | Angulation | 17°, 30° | 17°, 30° | |
    | Material | Ti-6A1-4V ELI | Ti-6A1-4V ELI | |
    | Principle of
    operation | Multi-unit Angled Abutment is a pre-
    manufactured prosthetic component directly
    connected to the endosseous dental implant
    and is intended for use as an aid in prosthetic
    rehabilitation. | NobelActive Multi Unit Abutment is a pre-
    manufactured prosthetic component directly
    connected to the endosseous dental implant
    and is intended for use as an aid in prosthetic
    rehabilitation. | |
    | Substantial Equivalence Discussion | | | |
    | The subject device has the same intended use, material, and design as the predicate devices.
    The subject device has slightly wider range of size to meet each patient needs and does not raise an issue in
    performance or safety since the size difference is very minor. The connection interface is also different but both
    features of Octa and Hex provides anti-rotational feature. | | | |

13

The subject device has the same intended use, material, surface treatment, connection interface, and design as the predicate devices.

The diameter of the subject device is the same as the reference device 2, yet the subject device has slightly wider range of gingival height. This wider range is to meet each patient needs and does not raise an issue in performance or safety since the size difference is very minor.

Meg-Rhein Abutment

14

CCM Abutment

The size fally of the subject device is covered by the releved 2.
The connection interface is also different but both features of Octa and Hex provides anti-rotational featur

15

Healing Abutment

16

Temporary Abutment

The connection interface is also different but both features of Octa and Hex provides anti-rotational feature.

17

Fuse Abutment

18

Angled Abutment

19

Multi-unit Angled Abutment

20

8. Non-Clinical Testing

  • · Sterilization validating testing has been performed in accordance with ISO 11137 and ISO 17665-1, 2 to verify the sterility assurance level (10th).
  • · The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
  • . The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analvsis.
  • · The fatigue tests were performed on the subject devices in accordance with ISO 14801. The worst case scenarios were chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". The fatigue testing demonstrates that the results of the subject devices are substantially equivalent to the predicate device.
  • · The fixture has the same material as the predicate device (K122231), and the abutments including the Fuse Abutment have the same material as the predicate device (K123988). The CCM Abutment also has the same material as the predicate device (K123988) made by our company. The biocompatibility of the predicate final products was evaluated under the previous 510K submissions.
  • · The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 .

9. Conclusion

Based on the similarities, we conclude that the AnyRidge Octa 1 Implant System is substantially equivalent to the predicate devices.