(427 days)
Not Found
No
The summary describes a dental implant system made of titanium alloy, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is described as an implant system that replaces the root of a missing tooth and supports restorations, which is a structural and restorative function, not a therapeutic one. The provided text indicates it is for mechanical support rather than treating a disease or condition.
No
Explanation: The provided text describes a dental implant system used for replacing missing teeth, which is a therapeutic rather than a diagnostic function. It replaces a missing body part and does not collect or analyze data to identify a disease, condition, or risk factor.
No
The device description explicitly states it is comprised of physical components made from surgical grade titanium alloys (implant and abutment), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used to replace missing teeth and support dental restorations. This is a medical device used in vivo (within the body).
- Device Description: The description details the physical components of the implant system (implant and abutment) made from surgical grade titanium alloys, designed to be placed in the jaw bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Biogenesis Implant System - Aticon is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Product codes
DZE, NHA
Device Description
The Biogenesis™ Implant System replaces the root of a missing tooth and is made from surgical grade titanium alloys. The Biogenesis™ Implant System is comprised of two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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)
The following non-clinical testing was conducted to validate its safety.
- Surface Roughness Analysis and Chemical Analysis to verify cleanness after surface treatment.
- Packaging and Sterilization Validation Tests:
Sterilization validation was provided for the components that are provided sterile and also for the components that are provided non-sterile and intended to be sterilized by the end user.
- Biocompatibility Test: ISO 10993-5 Cytotoxicity Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082213, K051614, K052823, 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
MAR 1 3 2013
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 02/06/2013
- Submitter
Biogenesis Co., Ltd. Mecha Zone #1109, SK Techno Park, 77-1, Sungsan-Dong, Sungsan-Gu, Chanwon-si, Gyeongnam, Republic of Korea, 642-971 Tel: +82-55-607-0345 Fax: +82-55-607-0347
- U.S Agent/Contact Person
LK Consulting Group USA, Inc. 1515 E Katella Ave Unit 2115, Anaheim, CA 92805 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
- Device
Trade Name: Biogenesis TM Implant System - Aticon Common Name: Dental Implant System Classification Name: Endosseous Dental Implant System Product Code: DZE, NHA Classification regulation: 21CFR872.3640
- Predicate Device:
GSIII internal fixture by Osstem (K082213) Prima Connex internal fixture by Lifecore (K051614) Implantium internal abutment by Dentium (K052823) EZ PLUS Implant system by Megagen (K070562)
- Description:
The Biogenesis™ Implant System replaces the root of a missing tooth and is made from surgical grade titanium alloys. The Biogenesis™ Implant System is comprised of two components, implant, which is the portion that goes into the jaw bone, and the abutment, which fits into the implant and provides a solid base for a crown or a denture.
1
6. Indication for use:
The Biogenesis Implant System - Aticon is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
- Basis for Substantial Equivalence
The Biogenesis™ Implant System is substantially equivalent to previously marketed devices. The design features and sizing of the components were also compared and the Biogenesis TM Implant System found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems. There are no significant differences between the Biogenesis™ Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
8. Non-clinical Testing
The following non-clinical testing was conducted to validate its safety.
- Surface Roughness Analysis and Chemical Analysis to verify cleanness after surface treatment.
- Packaging and Sterilization Validation Tests:
Sterilization validation was provided for the components that are provided sterile and also for the components that are provided non-sterile and intended to be sterilized by the end user.
- Biocompatibility Test: ISO 10993-5 Cytotoxicity Test
9. Conclusion
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium alloys and have the same surface treatments. The subject and the predicate devices encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter and height of the abutments.
Overall, Biogenesis™ Implant System has the following similarities to the predicate device: * has the same intended use.
-
- uses the same operating principle,
-
- incorporates the same basic design,
-
- incorporates the same material and the surface treatment.
Based on the similarities, we conclude that the Biogenesis™ Implant System is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Biogenesis Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Incorporated 1515 East Katella Avenue, Unit 2115 ANAHEIM CA 92805
Re: K120089
Trade/Device Name: Biogenesis 100 Implant System - Aticon Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 4, 2013 Received: March 7, 2013
Dear Ms. 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. 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.
3
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/6 description: The image shows the text "Kwame O Ulmer for". The words are written in a simple, sans-serif font. The text is arranged horizontally, with "Kwame" on the left, followed by "O Ulmer", and then "for" on the right. The letters "FDA" are in the middle of the text, with a design around them.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K120089 510(k) Number (if known):
Biogenesis™ Implant System - Aticon Device Name:
Indications For Use:
The Biogenesis Implant System - Aticon is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Biogenesis Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
Prescription Use (Per 21 CFR 801 Subpart D)
AND
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)
| Mary S. Runner -S | |
|---|---|
| Susan Runner, DDS, MA | |
| 2013.03.12 12:08:20 | |
| -04'00 |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices
| 510(k) Number: | K120089 |
|---|---|
| ---------------- | --------- |