(232 days)
Not Found
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide prosthetic support for dental restorations and restore a patient's chewing function, which are therapeutic interventions addressing a health condition.
No
The device is described as an "Internal Implant System" and its purpose is to "provide prosthetic support for dental restorations". This indicates it is a therapeutic device used for treatment, not for diagnosing a condition or disease.
No
The device description explicitly details physical components made of titanium and other materials, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be surgically placed in the jawbone to support dental restorations and restore chewing function. This is a direct surgical intervention and mechanical support, not a diagnostic test performed on biological samples.
- Device Description: The device is a physical implant made of titanium, along with various abutments. It's a physical component for surgical placement and prosthetic support.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device is clearly a medical device intended for surgical implantation and prosthetic support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The AnyOne™ Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form endosseous dental implant. The AnyOne™ Internal Implant System contains three types of fixtures, normal thread type, and special length type. This system is made from CP4 Titanium and Ti-6A1-4V-ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). 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 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 and cement retained restoration. This system has 3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm diameters for normal thread, 4.8, 5.8, 6.8, 7.8, 8.3mm diameters for deep thread, and 4.8, 5.3, 6.3, 7.3mm for special length fixtures. In addition, this system has 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for normal thread, 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for deep thread, and 7.0mm for special length fixtures.
Contained various abutments in the AnyOne™ Internal Implant System are straight and angled dental implant abutments intended to be connected to the fixture with screw, and to restore a patient's chewing function. The abutments contain Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling, Abutment, Zirconia Abutment, Gold Abutment, CCM Abutment, Temporary Abutment, Solid Abutment, Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included devices in the system are covered by this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular molar areas
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 fatigue testing was performed in accordance with ISO 14801 standard.
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.
XPEED AnyRidge Internal Implant System (K122231)
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
§ 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
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:
Dong Guk Ha MegaGenImplant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432
Device Information:
Device Name: AnyOne™ 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 Date Prepared: 1 1/20/2012
Contact /US agent: April Lee
KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
AUG 15 2013
General Description
The AnyOne™ Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form endosseous dental implant. The AnyOne™ Internal Implant System contains three types of fixtures, normal thread type, and special length type. This system is made from CP4 Titanium and Ti-6A1-4V-ELI and the surface treatment is done with S.L.A (Sand-blasted, Large grit, Acid-etched). 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 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 and cement retained restoration. This system has 3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm diameters for normal thread, 4.8, 5.8, 6.8, 7.8, 8.3mm diameters for deep thread, and 4.8, 5.3, 6.3, 7.3mm for special length fixtures. In addition, this system has 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for normal thread, 7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm lengths for deep thread, and 7.0mm for special length fixtures.
Contained various abutments in the AnyOne™ Internal Implant System are straight and angled dental implant abutments intended to be connected to the fixture with screw, and to restore a patient's chewing function. The abutments contain Cover Screw, Healing Abutment, EZ Post, Angled Abutment, Milling, Abutment, Zirconia Abutment, Gold Abutment, CCM Abutment, Temporary Abutment, Solid Abutment,
1
Burn-out Cylinder, Octa Abutment, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Plastic Cylinder, Flat Abutment, Ball Abutment, Meg-Rhein, ZrGEN Abutment, Multi-unit Abutment, Fuse Abutment, Flat CCM Cylinder, Flat Cover Screw, Flat Healing Abutment, Flat EZ Post Cylinder, Flat Temporary Cylinder, Flat Plastic Cylinder, and Flat Gold Cylinder. The fixtures, prosthetics, and surgical instruments are produced, and packaged separately. All included
devices in the system are covered by this submission.
Indication for use
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 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.
Predicate devices
- XPEED AnyRidge Internal Implant System (K122231) .
Substantial Equivalence Comparison
The AnyOne™ Internal Implant System has a substantially equivalent intended use as the identified predicate. The AnyOne™ Internal Implant System is similar in fundamental scientific technology to the predicate device 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 device are similar in size and materials.
There is no difference between the subject device and the predicate with respect to indications and technology.
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | Not available yet | K122231 |
| Device Name | AnyOne™Internal Implant | |
| System | XpeedAnyRige 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 |
2
| Design | AnyOne™ 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
abutments
Internal Hex | XpeedAnyRidge 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 abutments
Internal Hex | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Material | CP4 Titanium and Ti-6Al-4V-ELI | CP4 Titanium and Ti-6Al-4V-ELI | |
| Sterilization | Gamma sterilization | Gamma sterilization | |
| Fixture Diameter | Internal type
3.9, 4.3, 4.8, 5.3, 6.3, 7.3mm
(for normal thread)
4.8, 5.8, 6.8, 7.8, 8.3mm
(for deep thread)
4.8, 5.3, 6.3, 7.3mm
(for special length) | Internal type
4.0, 4.4, 4.9, 5.4, 5.9mm
(For normal ridge)
6.4, 6.9, 7.4, 7.9, 8.4mm
(For low ridge) | |
| Fixture Height | Internal type
7.0, 8.0, 9.5, 11.0, 12.5, 14.5mm
(for normal and deep thread)
7.0mm
(for special length) | Internal type
7.7, 9.2, 10.7, 12.2,
14.20, 17.2mm
(For normal ridge)
7.9, 9.4, 10.9, 12.4, 14.4mm
(For low ridge) | |
| Abutment | Diameters | Ø 3.8 - 10.0mm | Ø 4.0 - 10.0 mm |
| | Lengths | 7.7 - 18.7mm | 8.4 - 16.4 mm |
| Angulations of Angled
abutments | 15, 25° | 15, 25° | |
| Product Code | DZE, NHA | DZE, NHA | |
| Surface treatment | SLA | SLA | |
Non-Clinical Test Data
The fatigue testing was performed in accordance with ISO 14801 standard.
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 concludes that the AnyOne™ Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the figure. The figure is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15. 2013
MegaGen Implant Company, Limited C/O Ms. April Lee KoDent, Incorporated 325 North Puente Street, Unit B BREA CA 92821
Re: K123988
Trade/Device Name: AnvOne™ Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 8. 2013 Received: August 12, 2013
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 fiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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.
4
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K123988 510(K) Number (if known):
Device Name: AnyOne™ Internal Implant System
Indications for Use:
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 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.
AND/OR OverThe-Counter Use Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2013.08.15 09:17:05 -04'00
for M. Susan Runner, DDS, MA
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesi Devices Division of Anesthoolorology. Devices
510(k) Number: