Predicate Devices

AVANA Dental Implant System K051576, ITI Dental implant system K003552

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system with no mention of AI or ML features.

Therapeutic

No
The device is a dental implant system intended to support crowns, bridges, or overdentures, which are restorative dental procedures rather than therapeutic in nature. Its purpose is to replace missing teeth and restore function and aesthetics.

Diagnostic

No

Explanation: The device is an EBI Internal Implant system, described as a threaded, root form endosseous implant. Its intended use is to support crowns, bridges, or overdentures. It is a prosthetic device used for replacement or support, not for identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical implant system made of titanium, including various hardware components like abutments, screws, and the implant itself.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Description: The provided description clearly states that this device is a dental implant, a physical object placed inside the body (in vivo) to support dental prosthetics.
Intended Use: The intended use is for placement in the jawbone to support crowns, bridges, or overdentures. This is a surgical and restorative procedure, not a diagnostic test performed on a specimen.

The information provided describes a medical device used for treatment and restoration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

EBI dental implants are intended for immediate, delayed, or conventional placement in the maxillary and/or Mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

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

DZE, NHA

Device Description

The EBI Internal Implant system is a threaded, root form endosseous implant comprised of an internal octagon, 8° morse tapered device manufactured from pure Titanium ASTM F-67 and the Abutment from Titanium 6A-4V alloy E 11 -ASTM 136. The implant's external threaded surfaces are roughened to facilitate tissue and bone integration. The implant's self-tapping feature may be used with or without pre-tapping the bone. System components for restorative purposes include: screw retained and cement retained abutments, cover screws, healing abutments, and angled abutments.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary and/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)

Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act.

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.

AVANA Dental Implant System K051576, ITI Dental implant system K003552

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.

Not Found

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

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.

Summary

0

K073116

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.93

| Submitter | EBI Inc.
#289, Wuisong-ri, Apryang-myeon
Kyeongsan-city, Kyeongsangbook-do
712-825, Korea
Telephone 82-53-817-7767
Fax: 82-53-817-7768 | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact | Myung-bae Jegal, Managing Director | | |
| Date Prepared | February 21, 2008 | | |
| Device Name | EBI Internal Implant | | |
| Classification Name | Implant, endosseous, root-form DZE and Abutment implant,
dental, endosseous NHA | | |
| Device Classification | Class II
Dental Devices Panel
21 CFR 872.3640 and 872.3630 | | |
| Predicate Devices | AVANA Dental Implant System K051576
ITI Dental implant system K003552 | | |
| Performance | Performance standards have not been established by the FDA
under Section 514 of the Federal Food, Drug, and Cosmetic
Act. | | |
| Device Description | The EBI Internal Implant system is a threaded, root form
endosseous implant comprised of an internal octagon, 8°
morse tapered device manufactured from pure Titanium
ASTM F-67 and the Abutment from Titanium 6A-4V alloy E 11
-ASTM 136. The implant's external threaded surfaces are
roughened to facilitate tissue and bone integration. The
implant's self-tapping feature may be used with or without
pre-tapping the bone. System components for restorative
purposes include: screw retained and cement retained
abutments, cover screws, healing abutments, and angled
abutments. | | |
| Indications for Use | EBI dental implants are intended for immediate, delayed, or
conventional placement in the maxillary and/or Mandibular
arches to support crowns, bridges or overdentures in
edentulous or partially edentulous patients. | | |

1

K07311

Technical Characteristics

		Predicate Devices
Characteristics	EBI Internal Implant
System	AVANA Dental
Implant
K051576
OSSTEM Co., Ltd.	ITI Dental
Implant
K003552
Institut Straumann
AG
510(k)	-
Material
composition	Implant: Pure Titanium
Abutment: Ti Alloy	Implant: Pure
Titanium
Abutment: Ti Alloy	Implant: Pure
Titanium
Abutment: Ti Alloy
Design	Internal Morse Taper,
Internal Octagon	Internal Connection
Morse Taper, Internal
Octagon	Internal Connection
Morse Taper,
Internal Octagon
Implant
Diameter	3.3-4 mm	4.1-4.8 mm	3.3 - 4 mm
Implant Length	6-15 mm	8.4-15 mm	6 - 14mm
Sterilization
Method	Gamma	Gamma	Gamma
Indications for
use	Intended for immediate
delayed or conventional
placement in the
maxillary and/or
Mandibular arches to
support crowns, bridges,
or overdentures in
edentulous or partially
edentulous patients.	Intended for use in
partially or fully
edentulous mandibles
and maxillae, in support
of single or multiple-
unit restorations
including cement
retained, screw
retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support of fixed
bridgework.	Intended for
immediate, delayed,
or conventional
placement in the
maxillary and/or
Mandibular arches to
support crowns,
bridges or
overdentures in
edentulous or
partially edentulous
patients.
Surface
treatment	Resorbable Blasting
media (RBM)	Resorbable Blasting
media (RBM)	Resorbable Blasting
media (RBM)

Conclusion: In all respects, the EBI Internal Implants components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products listed in the table above.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

FEB 28 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, Incorporated C/O Mr. Daniel Kamm Principal Consultant Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K073116

Trade/Device Name: EBI Internal Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. Kamm:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

3

Page 2 - Mr. Kamm

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Syrite H. Michie Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

K073116

Indications for Use

510(k) Number (if known): K07

Device Name: EBI Internal Implant System

Indications For Use: Intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-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)

SumRennes

Division Sign-Off) livision of Anesthesiology, General Hospital fection Control, Dental Devices

Page 1 of 1

:0(k) Number: K073114