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 patient's chewing function: Smaller implants (less than ø6.0 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.

Device Description

The AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, rootform endosseous dental implant. The AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type, various abutments and instruments. This system is made from pure titanium and the surface treatment is done with R.B.M. The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.20, 17.20mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AnyRidge Internal Implant System, which is a dental implant system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data that would be typical for novel devices or AI/ML-driven diagnostics.

Therefore, the acceptance criteria and study information typically requested for AI/ML devices or novel medical devices with performance claims are largely not applicable in this context. The focus of this 510(k) is on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where information is not present:

1. A table of acceptance criteria and the reported device performance

For a 510(k) based on substantial equivalence for a dental implant system, the "acceptance criteria" are primarily related to meeting established standards and being comparable to predicate devices in terms of design, materials, intended use, and performance where tested (e.g., fatigue). There are no specific quantitative performance metrics (like sensitivity/specificity for a diagnostic AI) provided in this document as acceptance criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Material: CP4 Titanium	AnyRidge System: CP4 Titanium and its alloy
Sterilization: Gamma sterilization	AnyRidge System: Gamma sterilization
Design: Complies with FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments	AnyRidge System: Designed, manufactured, and tested in compliance with FDA's Class II special controls guidance document. Internal Hex connection.
Indication for Use: Mandible and Maxilla Endosseous Dental Implant & Accessories	AnyRidge System: Mandible and Maxilla Endosseous Dental Implant & Accessories
Fatigue Testing: Successful according to ISO 14801 standard	AnyRidge System: Fatigue testing performed successfully in accordance with ISO 14801 standard.
Substantial Equivalence: No new questions of safety or effectiveness compared to predicate devices.	The document concludes that the AnyRidge Internal Implant System performs "well or better than predicate device" based on provided information.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / not provided: This type of information (test set sample size, provenance related to clinical data for performance evaluation in the AI/ML sense) is not relevant for a 510(k) submission for a dental implant based on substantial equivalence. The "test set" here refers to the physical device's non-clinical testing (fatigue). The non-clinical test data for fatigue testing doesn't specify a "sample size" in the context of clinical or diagnostic data, but rather the number of samples tested for the engineering evaluation. No information on data provenance relating to patient populations is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / not provided: The device is a physical dental implant. There's no "ground truth" to be established by experts in the context of a diagnostic AI/ML device. The "truth" for fatigue testing is whether the implant withstands certain loads according to the ISO standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / not provided: No adjudication method is described as there is no diagnostic or interpretive data requiring expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable: This device is a dental implant, not a diagnostic AI or imaging system, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable: This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable (for AI/ML context): For the non-clinical fatigue testing, the "ground truth" is adherence to the ISO 14801 standard for dental implants. This involves objective engineering measurements of material strength and durability, not clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable: This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable: This device is not an AI/ML algorithm that requires a training set.

Summary

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K110955

NOV 222 2011

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter:

Hyun Jeong Kim MegaGen Implant Co., Ltd. 377-2 Kyochon-ri, Jain-Myun Gyeongsan, Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432

Contact / US Agent: April Lee KoDent, Inc. 325 N. Puente St. Units B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116

Date Prepared: 3/28/201 i

Device Name: AnyRidge Internal Implant System

Device Information:

Device Name: AnyRidge Internal Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640

Device Description

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Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.

Indication for use

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 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 occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Non-Clinical Test Data

Fatigue testing is performed successfully in accordance with ISO 14801 standard.

Predicate devices

EZ Plus Implant system (K070562) .
Rescue Internal Implant system (K073058) .

The AnyRidge Internal Implant System has a substantially equivalent intended use as the identified predicates. All Implant System are used for mandible and maxilla endosseous dental implant and accessories. The AnyRidge Internal Implant System is similar in fundamental scientific technology to the predicate devices in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium. The subject and predicate devices are similar in size, surface treatment and materials. When compared with predicate devices, no new questions of safety or effectiveness have been raised for the AnyRige Internal Implant System.

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Substantial Equivalence Comparison
	Subject Device	Predicate Device
510(k) Number	Not available yet	K070562 K073058
Device Name	AnyRige Internal Implant System	Rescue Internal Implant System
Manufacturer	MegaGen Implant Co., Ltd	MegaGen Implant Co., Ltd
Indications for Use	Mandible and Maxilla Endosseous Dental Implant & Accessories	Mandible and Maxilla Endosseous Dental Implant & Accessories
Design	AnyRidge Internal Implant System, abutments and accessories have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutmentsInternal Hex	EZ Plus Implant System, abutments and accessories have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutmentsInternal and External HexRescue Internal Implant System, abutments and accessories have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutmentsInternal Tri-lobe type indexing feature Anti-rotational type
Material	CP4 Titanium and its alloy	Commercial pure titanium CP4 Titanium and its alloy
Sterilization	Gamma sterilization	Gamma sterilization
Fixture Diameter	Internal type4.0, 4.4, 4.9, 5.4, 5.9mm(For normal ridge)6.4, 6.9, 7.4, 7.9, 8.4mm(For low ridge)	Internal type:3.3, 4.0, 5.0mmExternal type:3.3, 4.0, 5.0mmInternal Type6.0, 6.5, 7.0, 7.5, 8.0mm
Fixture Height	Internal type7.7, 9.2, 10.7, 12.2, 14.20, 17.20mm(For normal ridge)7.9, 9.4, 10.9, 12.4, 14.4mm(For low ridge)	Internal type:8.0, 10.0, 11.0, 13.0, 15.0, 18.0mmExternal type:8.0, 10.0, 11.0, 13.0, 15.0, 18.0mmInternal type5.0, 6.0, 7.0mm
Abutment Diameters	Ø4.0-10.0mm	Ø4.0-6.0mm Ø6.0-10.0mm
Lengths	8.4-16.4mm	9.0-17.2mm 8.3-14.65mm

Substantial Equivalence Comparison

ﺗﺮ

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Product Code	DZE, NHA	DZE, NHA	DZE
Surface treatment	RBM	RBM	RBM
Angulations ofAngled abutments	15, 25°	15, 25°	N/A

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification EZ Plus Implant system (K070562S) and Rescue Internal Implant system (K073058) concludes that the new device, Anyridge Internal Implant System performs well or better than predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service :

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

Megagen Company, Limited C/O Ms. April Lee Consultant / US Agent KoDent. Incorporated 325 North Puente Street, Unit B Brea, California 92821

NOV 222 2011

Re: K110955

Trade/Device Name: AnyRidge Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 19, 2011 Received: October 24, 2011

Dear Ms. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

...

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Page 2 - Ms. Lee

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(K) Number (if known): K || 0 955

Device Name: AnyRidge Internal Implant System

Indication for use :

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

OverThe-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devic

510(k)

Regulation Number and Section

§ 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.