(155 days)
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for treatment of missing teeth, restoring chewing function, and supporting prosthetic devices, which are all therapeutic functions.
No
The device is an implant system designed to restore chewing function or support overdentures, not to diagnose a condition.
No
The device description explicitly states it is a "one-piece endosseous dental implant" made of "Unalloyed Titanium (G4)", which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental implant system used for temporary support of prosthetic devices or overdentures in patients. This is a surgical and prosthetic application within the body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed in 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a physical implant.
N/A
Intended Use / Indications for Use
The S-MiNi Implant System is divided into two types:
Cement Type
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the · mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Ball Type
The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The S-MiNi System has two types, cement type and ball type.
The S-MiNi Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is a made of Unalloyed Titanium (G4). The surface was granted with microscopic roughness through the RBM surface treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary lateral incisors or the mandibular central and lateral incisors
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)
Bench tests including visual, size, package, package seal efficacy, compressive load, and retention force testing, were performed successfully.
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.
K080594, K051018, K072959, K080126
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
KIJિટ્રપતિ
510(K) SUMMARY
Submitter:
Hee Seok Jung neobiotech Co., Ltd. e-space #103, 104-1, 104-2, 105, 106, 205, 212, 312 10th floor, Guro-dong, Guro-gu, Seoul, Korea 152-789 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: S-MiNi Implant System Classification Name: Implant, Endosseous, Root-Form Common Nmae: Endosseous Dental Implant Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date of Submission: 8/25/2011
Device Description
The S-MiNi System has two types, cement type and ball type.
The S-MiNi Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is a made of Unalloyed Titanium (G4). The surface was granted with microscopic roughness through the RBM surface treatment.
Indication for use
.
The S-MiNi Implant System is divided into two types:
Cement Type
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the · mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
Ball Type -
The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
FEB - 3 2012
1
Performance Standards
Bench tests including visual, size, package, package seal efficacy, compressive load, and retention force testing, were performed successfully.
Predicate devices
-
Cement Type .
MS Implant(Narrow Reidge) by OSSTEM Implant., Ltd, K080594 Intermezzo TM Implant System by Megagen Co., ltd. K051018 -
Ball Type .
MS Implant (Denture) by OSSTEM Implant., Ltd., K072959
DIO Protem Implant System by DIO Department, DSI, Inc., K080126
Comparison Chart
| Cement type | |||
|---|---|---|---|
| product Name | S-MiNi Implant | MS Implant | IntermezzoTMImplant |
| System | |||
| 510(k) | N/A | K080594 | K051018 |
| Manufacturer | neobiotech Co., | ||
| Ltd | OSSTEM | ||
| Implant., Ltd | MegaGen Co., Ltd | ||
| Shape | Image: S-MiNi Implant | Image: MS Implant | Image: Intermezzo Implant |
| Intended use | Identical to the | ||
| predicate | The MS System is | ||
| intended to use in | |||
| the treatment of | |||
| missing | |||
| mandibular central | |||
| and lateral | |||
| incisors to support | |||
| prosthetic device, | |||
| such as artificial | |||
| teeth, in order to | |||
| restore chewing | |||
| function in | |||
| partially | |||
| edentulous. | The Intermezzo TM | ||
| Implant Systems are | |||
| intended to load | |||
| immediately in | |||
| partially or fully | |||
| edentulous mandibles | |||
| and maxillae to serve | |||
| as temporary support | |||
| for provisional | |||
| prosthetic device | |||
| during the healing | |||
| phase of permanent | |||
| endosseous dental | |||
| implants. | |||
| Comparison of | |||
| Material | Titanium Grade 4 | ||
| of ASTM F 67 | Ti-6AL-4V ELI | ||
| Alloy of ASTM F | |||
| 136 | CP Titanium G3 |
2
| Dia(Ø) | 2.0/2.5/3.0/3.5 | 2.5/3.0 | 1.6/2.0/2.5/3.1 | |
|---|---|---|---|---|
| Device | ||||
| design | Cuff(mm) | 2 | 2.5 | - |
| Post(mm) | 10 | 7 | - | |
| Lengrh(mm) | 7.0/8.5/10.0/11.5/ | |||
| 13.0/15.0 | 10.0/13.0/15.0 | 7.0/8.5/10.0/11.5/13.0/15.0 | ||
| Surface Treatment | RBM | RBM | RBM | |
| Biocompatibility | Yes | Yes | Yes | |
| Sterilization | Gamma | |||
| Sterilization | Gamma | |||
| Sterilization | Gamma Sterilization |
ﻠﻴﺮﺍﺕ 场
ਿੰਗ ਸਿੰਘ ਸੀ।
1981 238 1
| Ball type | ||||
|---|---|---|---|---|
| product Name | S-MiNi Implant | MS Implant | ||
| (Denture) | DIO Protem Implant | |||
| system | ||||
| 510(k) | N/A | K072959 | K080126 | |
| Manufacturer | neobiotech Co., | |||
| Ltd | OSSTEM | |||
| Implant., Ltd | MegaGen Co., Ltd | |||
| Shape | Image: S-MiNi Implant | Image: MS Implant | Image: DIO Protem Implant | |
| Intended use | Identical to the | |||
| predicate | The MS System | |||
| (Denture) is | ||||
| intended to be | ||||
| place in the bone of | ||||
| the upper or lower | ||||
| jaw arches to | ||||
| provide support the | ||||
| prosthetic devices | ||||
| to restore the | ||||
| patient's chewing | ||||
| function, including | ||||
| the denture | ||||
| stabilization. MS | ||||
| System (Denture) | ||||
| is intended for | ||||
| single use only. | The DIO Protem | |||
| Implant Systems are | ||||
| intended to load | ||||
| immediately in partially | ||||
| or fully edentulous | ||||
| mandibles and maxillae | ||||
| to serve as temporary | ||||
| support for provisional | ||||
| prosthetic device during | ||||
| the healing phase of | ||||
| permanent endosseous | ||||
| dental implants. | ||||
| Comparison of | ||||
| Material | Titanium Grade 4 | |||
| of ASTM F 67 | Ti-6AL-4V ELI | |||
| Alloy of ASTM F | ||||
| 136 | Ti-6AL-4V ELI Alloy | |||
| of ASTM F 136 | ||||
| Device | ||||
| design | Dia(Ø) | 2.0/2.5/3.0/3.5 | 2.5/3.0 | 2.0/2.5 |
| Cuff(mm) | 3.0/4.0 | 2.0/4.0 | 2.0/4.0 | |
| Length(mm) | 7.0/8.5/10.0/11.5/ | |||
| 13.0/15.0 | 10.0/13.0/15.0 | 8.0/10.0/12.0/14.0 | ||
| Surface Treatment | RBM | RBM | RBM | |
| Biocompatibility | Yes | Yes | Yes | |
| Sterilization | Gamma | |||
| Sterilization | Gamma | |||
| Sterilization | Gamma Sterilization |
3
Image /page/3/Picture/0 description: The image shows a scattering of small, dark dots against a white background. The dots are clustered into two distinct groups, one on the left and one on the right side of the image. The clusters are irregular in shape, with the dots appearing randomly distributed within each group.
Summary of Substantial Equivalence Comparison
The Cement type of S-MiNi Implant system is the same device characteristics as the predicate devices, The MS System(Narrow Ridge) and Intermezzo ™ Implant System; intended use, material, design and use concept are similar.
The Ball type of S-MiNi Implant system is the same device characteristics as the predicate devices, The MS System(Denture) and DIO Protem Implant System; intended use, design and use concept are similar.
Based on the comparison of intended use and technical features, S-MiNi Implant System are substantially equivalent to the predicate 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 neobiotech Co., Ltd. concludes that the S-MiNi Implant system is substantially equivalent to predicate devices as described herein.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Neobiotech Company, Limited Ms. April Lee Consultant Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821
FEB - 3 2012
Re: K112540
Trade/Device Name: S-MiNi Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 3, 2012 Received: February 2, 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 Eederal Register.
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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 ucm 1 15809.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 vours.
for Anthony J. Watson
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
6
Indication for Use
510(K) Number (if known): K \ 1254)
Device Name: S-MiNi Implant System
Indications for Use:
The S-MiNi Implant System is divided into two types:
Cement Type -
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
-Ball Type
The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
OverThe-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF unno NEEDED
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Hospital Hospital Hospital Infection Control, Dental Devices
510(k) Number:
1