K Number
K073486
Device Name
DENTIS DENTAL IMPLANT SYSTEM
Manufacturer
Date Cleared
2008-04-04

(114 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dentis Dental Implant system is an endosseous dental implant that is indicated to use 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.
Device Description
The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface. The System includes surgical instruments such as twist drill, bone tap, Trephine
More Information

Not Found

No
The description focuses on the physical components, materials, and surgical procedures of a dental implant system, with no mention of AI or ML.

Yes
The device, a dental implant system, acts as a root form to restore a patient's chewing function, thereby providing a therapeutic benefit for a medical condition (loss of teeth).

No

The device is a dental implant system used for surgical placement and prosthetic attachment to restore chewing function, not for diagnosing conditions.

No

The device description explicitly states it is comprised of dental implants, surgical instruments, and prosthetic components, which are physical hardware.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The Dentis Dental Implant System is a physical implant and associated surgical tools designed to be surgically placed within the patient's jawbone. It is a medical device used for structural support and restoration of function, not for analyzing biological samples.
  • Intended Use: The intended use is for surgical placement in the jaw to support prosthetic appliances and restore chewing function. This is a surgical and restorative procedure, not an in vitro diagnostic test.

The information provided clearly describes a surgical implant system, not a device used for testing biological samples outside of the body.

N/A

Intended Use / Indications for Use

The Dentis Dental Implant System is an endosseous dental implant that is indicated to use 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

Product codes

DZE

Device Description

The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface.

The System includes surgical instruments such as twist drill, bone tap, Trephine

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper and lower jaw arches, anterior mandible

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)

Laboratory testing was conducted to determine device functionality and conformance to design input requirements.

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

Not Found

Predicate Device(s)

K061709, K070562

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

0

1, 162

K073486

510(K) SUMMARY

APR - 4 2008

| 14-1. Submitter | Dentis Co. Ltd.
1-72 Woram-Dong, Dalseo-Gu, Daegu, Korea
Phone: 82-53-583-2804, Fax : 82-53-583-2806 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 14-2. US Agent /
Contact Person | PhD. Chang Dae Kyu
13340 E. Firestone Blvd. Suite J
Santa Fe Springs, CA 90670
Phone : 562-404-8466, Fax : 562-404-2757 |
| 14-3. Date Prepared | December 07, 2007 |
| 14-4. Device Name | DENTIS DENTAL IMPLANT SYSTEMS
(Internal / External / Submerged Type) |
| 14-5. Classification Name | Endosseous Dental Implant System |
| 14-6. Device
Classification | Class II
Dental Devices panel
21 CFR § 872.3640 |
| 14-7. Predicate Devices | SM® IMPLANT SYSTEMS(K061709) |

14-7. Predicate DevicesSM IMPLANT SYSTEMS(K061709)
E Z® IMPLANT SYSTEMS (070562)
14-8. PerformanceLaboratory testing was conducted to determine device functionality
and conformance to design input requirements.

14-9. Device Description

The Dentis Dental Implant System is comprised of dental implants, surgical instruments and prosthetic components. The system is designed for conventional two-stage for single and multiple unit prosthetics. The Dentis Dental Implant System consists of machined titanium, screw-form dental implant Ø 3.5mm. Ø 3.7mm, Ø 4.1mm, Ø 4.3mm, Ø 4.8mm, Ø 5.5mm, 6.0mm in diameter. They are available in length of 7-14 mm. The implant's raw material is titanium and its alloys for surgical implant applications (as per ASTM-F-67, ASTM-F-136). Surfaces include as machined surfaces, grit blasted and surfaces treated with Resorbable Blast Media (RBM) roughened surface.

The System includes surgical instruments such as twist drill, bone tap, Trephine

1

Dentis Dental Implant System

K073486

202

12-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek . Dentis Dental Implant Systems(Internal / External / Submerged Type Implant Fixtures, Protective Cap, and Implant System Surgery Tray) will be packaged.

12-11. Intended Use

The Dentis Dental Implant System is an endosseous dental implant that is indicated to use 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants. Patients must be subject for dental treatment with endosseous implants.

12-12. Substantial Equivalence Comparison

The Dentis Dental Implant system has a substantially equivalent intended use as the identified predicates.(K061797, K070562) All implants are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible or maxilla. The Dentis Dental Implants are similar in fundamental scientific technology to the predicate devices(K061797, K070562) in that they are all threaded, root form implants constructed of titanium. The subject and predicate devices are similar in size and materials, are sterilized via gamma irradiation. The Dentis Dental Implant system and the predicates include instruments to assist with the implant procedure. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Dental Implant System.

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

APR - 4 2008

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 4 2008

Dentis Company, Limited C/O Chang Dae Kyu Ph.D U.S. Agent Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K073486

Trade/Device Name: Dentis Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 24, 2008 Received: March 24, 2008

Dear Dr. Kyu:

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 - Dr. Kyu

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.

Suetta 4. Michael: Owed

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

K073486

Indication for Use

510(K) Number (if known):

): K073486

Device Name: Dentis Dental Implant System

Indications For Use:

The Dentis Dental Implant system is an endosseous dental implant that is indicated to use 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. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

్రి Prescription Use AND/OR Over – The-Counter Use (Part 21 CFR 801 Subpart D) (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Perry
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073456

63