(70 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 surgically placed to provide prosthetic support and restore chewing function, which addresses a medical condition or improves a health outcome.
No
This device is a dental implant system intended for surgical placement to provide prosthetic support. It is designed to restore chewing function and replace missing teeth, not to diagnose medical conditions.
No
The device description explicitly states it consists of machined titanium, screw-form, root-form endosseous dental implants, various abutments, and instruments. These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the mouth to support dental restorations and restore chewing function. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical implant made of titanium, along with associated abutments and instruments for surgical placement. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device, specifically a dental implant system, but it falls under the category of surgical implants rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Xpeed 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Xpeed AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, root-form endosseous dental implant. The Xpeed 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 CP Titanium, Gr. 4 and Ti-6Al-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 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 multimount 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, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures. Fixtures, the prosthetics, and the 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)
Appearance, Dimension, Packing, Extraction, and Sterility tests were performed to prove that the modifications do not affect the safety and effectiveness of the subject device.
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.
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
K12 2231
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 MegaGen Implant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 82-53-857-5432 Fax:
Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B
Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
Device Information:
Device Name: Xpeed 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 Date Prepared: 8/21/2012
Device Description
The Xpeed AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, root-form endosseous dental implant. The Xpeed 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 CP Titanium, Gr. 4 and Ti-6Al-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 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 multimount 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, 14.2, 17.2mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.
The purpose of this submission is
- to modify the surface treatment from R. B. M to S.L.A
- to add new instruments such as impression driver, mount removal driver, point trephine bur, impression coping, and guide pin
- to modify the design of the path finders and Impression Copings to provide convenience
4 2012
OCT
1
Indication for use
The Xpeed 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.
Predicate devices
Substantial Equivalence Comparison
The Xpeed AnyRidge Internal Implant System has a substantially equivalent intended use as the identified predicate. The Xpeed AnyRidge 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. When compared with predicate device, no new questions of safety or effectiveness have been raised for the Xpeed AnyRige Internal Implant System.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(k) Number | K122231 | K110955 | K061176 |
| Device Name | Xpeed AnyRige | ||
| Internal Implant | |||
| System | AnyRige Internal | ||
| Implant System | Straumann Anodized | ||
| Neck Implants | |||
| Manufacturer | MegaGen Implant Co,. | ||
| Ltd | MegaGen Implant Co., | ||
| Ltd | Straumann | ||
| Indications for Use | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant & Accessories | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant & Accessories | Mandible and Maxilla | ||
| Endosseous Dental | |||
| Implant | |||
| Design | Xpeed 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 abutments | 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 abutments | -Single-stage | ||
| or two-stage |
- Single-tooth and/or
multiple tooth
applications
-Neck diameter :
3.5mm, 4.8mm |
2
| Material | CP Titanium, Gr.4 and
Ti-6Al-4V, ELI | CP Titanium, Gr.4 and
Ti-6Al-4V, ELI | CP4 Titanium | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|---|
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | |
| Fixture Diameter | 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) | 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) | 3.3, 4.1, 4.8mm | |
| Fixture Height | 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) | Internal type
7.7, 9.2, 10.7, 12.2,
14.2, 17.2mm
(For normal ridge)
7.9, 9.4, 10.9, 12.4,
14.4mm
(For low ridge) | 8, 10, 12, 14mm | |
| Abutment | Diameters | $\varnothing$ 4.0 - 10.0 mm | $\varnothing$ 4.0 - 10.0 mm | - |
| | Lengths | 8.4 - 16.4 mm | 8.4 - 16.4 mm | - |
| Angulations of Angled
abutments | 15, 25° | 15, 25° | - | |
| Product Code | DZE, NHA | DZE, NHA | DZE | |
| Surface treatment | SLA | RBM | SLA | |
Non-Clinical Test Data
Appearance, Dimension, Packing, Extraction, and Sterility tests were performed to prove that the modifications do not affect the safety and effectiveness of the subject device.
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 Xpeed AnyRidge Internal Implant system is safe and effective and substantially equivalent to predicate devices as described herein.
3
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 eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is in all caps and is arranged around the top and left side of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
OCT 4 2012
Megagen Implant Company, Limited C/O Ms. April Lee Kodent, Incorporated 325 North Puente Street, Unit B Brea, California 92821
Re: K122231
Trade/Device Name: Xpeed AnyRidge Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 31, 2012 Received: September 6, 2012
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.
4
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,
Nh 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
5
Indication for Use
510(K) Number (if known): K12 223
Device Name: Xpeed AnyRidge Internal Implant System
Indications for Use:
The Xpeed 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.
Prescription Use (Part 21 CFR 801 Sub part D) AND/OR
Over The-Counter Use (21 CFR 807 Sub part C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kummer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental De
510(k) Number: K022327