K Number
K132178
Device Name
MOSTDI DENTAL IMPLANT SYSTEM
Date Cleared
2014-04-30

(289 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.
Device Description
Mostdi™ dental implant system consists of one piece screw type endosseous dental implants manufactured from titanium alloy and intended to provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function.
More Information

Not Found

No
The summary describes a physical dental implant system and its mechanical and biological performance, with no mention of software, algorithms, or AI/ML terms.

No
The device is a dental implant system used to provide support for prosthetic devices to restore chewing function, which is a structural support rather than a therapeutic treatment for disease or injury.

No

The device description clearly states its purpose is to "provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function," which is a treatment or restorative function, not a diagnostic one.

No

The device description clearly states it is a "screw type endosseous dental implant manufactured from titanium alloy," which is a physical hardware device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
  • Device Description: The Mostdi™ dental implants are physical devices made of titanium alloy that are surgically implanted into the jawbone. They are used to support prosthetic devices.
  • Intended Use: The intended use is to provide support for dentures and bridges to restore chewing function, which is a mechanical and structural purpose, not a diagnostic one.
  • Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, detection of biomarkers, or any other diagnostic function.

Therefore, the Mostdi™ dental implant system falls under the category of a medical device, but not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Product codes (comma separated list FDA assigned to the subject device)

DZE

Device Description

Mostdi™ dental implant system consists of one piece screw type endosseous dental implants manufactured from titanium alloy and intended to provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 were reviewed to support the performance of Mostdi™ dental implants: Fatigue tests to ISO 14801/ static test, sterilization validation, shelf life testing, surface analysis & biocompatibility testing.

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.

K130140, K070601, K121707, K031106

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

K132178

APR 3 0 2014

510(K) SUMMARY

Submitter:

Ang Moe Keng Mostdi Innovations Sdn Bhd No 5, Jalan Damai Puspa 1, Alam Damai, 56000 Kuala Lumpur Malaysia Phone: +603-9101-1089 +603-9101-0834 Fax:

Consultant /US agent:

Susan Park Kodent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 USA Phone: 714-525-0114 Fax: 714-525-0116

Device Information

Device Name: Mostdi Dental Implant System Classification Name: Endosseous dental implant Common Name: Dental implant Panel: Dental Classification: Class II Product Code: DZE Regulation number: 21 CFR 872.3640 Date prepared: 7/10/2013

General Description

Mostdi™ dental implant system consists of one piece screw type endosseous dental implants manufactured from titanium alloy and intended to provide support for prosthetic devices such as bridges and removable dentures in order to restore a patient's chewing function.

Indications for Use

The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Testing

The following were reviewed to support the performance of Mostdi™ dental implants: Fatigue tests to ISO 14801/ static test, sterilization validation, shelf life testing, surface analysis & biocompatibility testing.

1

Substantial Equivalence

い・

Areas of ComparisonMostdi Dental Insplant SystemIntra-Lock® OP Dental ImplantsMini Drive-Lock™ Dental Implant SystemLew Mini O-Ball implantIMTEC Sendax MDI and MDI Plus
Regulatory StatusPresent ApplicationPredicatePredicatePredicatePredicate
510(k) NumberK132178K130140K070601K121707K031106
MaterialTi6Al4V ASTM F-136Ti6Al4V ASTM F-136Ti6Al4V ASTM F-136Ti6Al4V ASTM F-136Ti6Al4V ASTM F-136
One Piece/ Two PieceOne pieceOne pieceOne pieceOne pieceOne piece
Type Implant SurfaceRoughened-light sand blast & acid etchBlastedN/ABlasted and clean (SLA equivalent), machined surface, SE to IMTEC K031106N/A
Dimensions (mm)OSH: 2.5, 3.0 diameter and 8,10,12,13,14,16 threaded length
MXO: 3.5 diameter and 8, 10 threaded length
PEO: 3.8 diameter In 10, 12, 14, 16, 18 threaded length
POH: 2.5, 3.0 diameter in 8, 10, 12, 13, 14, 16 threaded length
MXP: 3.5 diameter for 8, 10 threaded length
PEP: 3.8 diameter for 10, 12, 14, 16, 18 threaded length3.0, 3.75, 4.0, 4.75 diameter, 10 - 15 threaded length2.0. 2.5 diameter, 10, 11.5, 13, 15, 18 threaded length2.0, 2.5, 3.0 diameter, 10, 13, 15, 17, 18 threaded lengthN/A
Product CodeDZEDZEDZEDZEDZE
Indications for UseThe Mostdi " dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also Indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral and central incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate ocdusal loading in order to restore normal teeth function, 3.75mm, 4.0nm and 4.75mm Intra-LockS OP Dental Implants: Intra-Lock") implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and toMini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Dive-Lock TM Dental Implants are indicated for long-term maxaltary and mandibular tissue- supported denture stabilization, Multiple implants should be used and may be restored after a period of time or placed in immediate function.The Park Dental Research Corporation's LEW O-ball implant system is a self- tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini 0-ball implant may be used for inter-radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention. The 2.0mm, 2.5 mm, and 3.0 mem diameter are intended to support single or multi-unit restorations in both long- term and temporary applicationsThe MDI and MDI PLUS are self-tapping titanium threaded screws Indicated for long-term intra-bony applications. Additionally, the MDI may also be used for inter. radicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full partial endentulism, and employing minimally invasive surgical intervention,

.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . .

.

.

.

.

·

2

| | | replacement to full arch
reconstruction. Intra-Lock®
Implants are intended
for immediate function on single
tooth and/or multiple tooth
applications when good primary
stability is achieved, with
appropriate occlusal loading, in
order to restore normal teeth
functions. | | | |

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Summary of Substantial Equivalence Comparison

The Mostdi Dental Implant System has the same device characteristics as the predicate devices. Intended use, material, design and use concept are similar.

Slight differences in design characteristics do not affect the application of the device. Therefore, we state that Mostdi™ dental implants is substantially equivalent to predicate devices.

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, Mostdi Innovations Sdn Bhd concludes that Mostdi Dental implant System is substantially equivalent to predicate devices as described herein.

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 30, 2014

Mostdi Innovations Sdn Bhd C/O Ms. Susan Park Kodent, Incorporated 325 North Puente Street, Unit B Brea, CA 92821

Re: K132178

Trade/Device Name: Mostdi Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 1, 2014 Received: April 1, 2014

Dear Ms. Park:

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. Park

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(K) Number (if known) K132178

Device Name: Mostdi Dental Implant System

Indications for Use:

The Mostdi ™ dental implants are indicated to provide support for removable dentures, and fixed bridges for the treatment of partial or full edentulism. Multiple implants are to be used and can be immediately loaded if good primary stability is achieved and with appropriate occlusal loading.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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)

Sheena A. Green =S 2014.05.01 11:37:44 00'