MOSTDI DENTAL IMPLANT SYSTEM

K132178 · Mostdi Innovations Sdn Bhd · DZE · Apr 30, 2014 · Dental

Device Facts

• Record ID: K132178
• Device Name: MOSTDI DENTAL IMPLANT SYSTEM
• Applicant: Mostdi Innovations Sdn Bhd
• Product Code: DZE · Dental
• Decision Date: Apr 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Mostdi Dental Implant System consists of one-piece, screw-type endosseous dental implants fabricated from Ti6Al4V titanium alloy. Designed for surgical placement into the maxilla or mandible by dental professionals to provide support for prosthetic devices, including removable dentures and fixed bridges. The implants function as anchors to restore patient chewing function. The system is intended for use in cases of partial or full edentulism. Clinical application involves surgical implantation; immediate loading is permitted if primary stability is achieved. The device serves as a mechanical foundation for dental restorations, benefiting patients by stabilizing prosthetics and improving oral function.

Clinical Evidence

Bench testing only. Performance was supported by fatigue testing per ISO 14801, static testing, sterilization validation, shelf-life testing, surface analysis, and biocompatibility testing. No clinical data was provided.

Technological Characteristics

One-piece, screw-type endosseous dental implant. Material: Ti6Al4V titanium alloy (ASTM F-136). Surface: Roughened via light sand blast and acid etch. Dimensions: Diameters 2.5mm, 3.0mm, 3.5mm, 3.8mm; lengths 8mm to 18mm. Sterilization: Provided sterile. Mechanical principle: Threaded screw for osseointegration.

Indications for Use

Indicated for patients with partial or full edentulism requiring support for removable dentures or fixed bridges. Implants are intended for use in multiple configurations and may be immediately loaded provided good primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Intra-Lock® OP Dental Implants (K130140)
• Mini Drive-Lock™ Dental Implant System (K070601)
• Lew Mini O-Ball implant (K121707)
• IMTEC Sendax MDI and MDI Plus (K031106)

Submission Summary (Full Text)

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## 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: [phone] [phone] Fax:

#### Consultant /US agent:

Susan Park Kodent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 USA Phone: [phone] Fax: [phone]

#### 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.

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### Substantial Equivalence

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| Areas of Comparison | Mostdi Dental Insplant System | Intra-Lock® OP Dental Implants | Mini Drive-Lock™ Dental Implant System | Lew Mini O-Ball implant | IMTEC Sendax MDI and MDI Plus |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Status | Present Application | Predicate | Predicate | Predicate | Predicate |
| 510(k) Number | K132178 | K130140 | K070601 | K121707 | K031106 |
| Material | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-136 | Ti6Al4V ASTM F-136 |
| One Piece/ Two Piece | One piece | One piece | One piece | One piece | One piece |
| Type Implant Surface | Roughened-light sand blast & acid etch | Blasted | N/A | Blasted and clean (SLA equivalent), machined surface, SE to IMTEC K031106 | N/A |
| Dimensions (mm) | OSH: 2.5, 3.0 diameter and 8,10,12,13,14,16 threaded length<br>MXO: 3.5 diameter and 8, 10 threaded length<br>PEO: 3.8 diameter In 10, 12, 14, 16, 18 threaded length<br>POH: 2.5, 3.0 diameter in 8, 10, 12, 13, 14, 16 threaded length<br>MXP: 3.5 diameter for 8, 10 threaded length<br>PEP: 3.8 diameter for 10, 12, 14, 16, 18 threaded length | 3.0, 3.75, 4.0, 4.75 diameter, 10 - 15 threaded length | 2.0. 2.5 diameter, 10, 11.5, 13, 15, 18 threaded length | 2.0, 2.5, 3.0 diameter, 10, 13, 15, 17, 18 threaded length | N/A |
| Product Code | DZE | DZE | DZE | DZE | DZE |
| 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. | 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 to | Mini 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 applications | The 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, |

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

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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'