INCLUSIVE MINI IMPLANT

K100932 · Prismatik Dentalcraft, Inc. · DZE · Dec 27, 2010 · Dental

Device Facts

• Record ID: K100932
• Device Name: INCLUSIVE MINI IMPLANT
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 27, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Inclusive® Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive® Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

Device Story

Inclusive® Mini Implant is a one-piece, root-form, screw-type endosseous dental implant; functions as both implant and abutment. Manufactured from Ti6Al-4V ELI titanium alloy (ASTM F136). Features self-tapping threads for bone compression; blasted and etched surface for osseointegration; 3.0mm diameter models include microthreads at intra-osseous collar. Available in various diameters (2.2mm, 2.5mm, 3.0mm) and lengths (10mm, 13mm, 15mm). Used by dental clinicians in clinical settings for denture stabilization. Implant provides immediate loading and long-term fixation for edentulous patients. Clinical benefit includes stabilization of dentures during standard implant healing or as a long-term solution.

Clinical Evidence

Bench testing only. Verification and validation studies conducted per FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants (2004). Testing included static and fatigue strength, sterilization validation, bioburden, shelf life, packaging integrity, cytotoxicity, and independent clinician evaluations.

Technological Characteristics

Material: Ti6Al-4V ELI titanium alloy (ASTM F136). Design: One-piece, root-form, self-tapping screw. Surface: Blasted and etched. Dimensions: 2.2-3.0mm diameter; 10-15mm length. Features: O-Ball prosthetic head, transgingival collar. Sterilization: Provided sterile.

Indications for Use

Indicated for patients requiring long-term or provisional stabilization of dentures, including immediate loading in the presence of primary stability and appropriate occlusal loading.

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

• IMTEC Sendax MDI and MDI Plus (K031106)
• IMTEC MDI MII One-Piece Implant, 2.9mm (K08165)

Submission Summary (Full Text)

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# K100932

## 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.

### A. SUBMITTER INFORMATION

| Company Name: | Prismatik Dentalcraft, Inc. |
|--------------------------------|-------------------------------------------------------|
| Company Address: | 4141 Mac Arthur Boulevard<br>Newport Beach, CA 92660 |
| Company Phone:<br>Company FAX: | [phone]<br>[phone] |
| Contact Person: | Keith D. Àllred<br>Kathleen Dragovich, [phone] |
| Date Summary Prepared: | December 13, 2010 |

#### B. DEVICE IDENTIFICATION

| Trade/Proprietary Name: | Inclusive® Mini Implant |
|-------------------------|---------------------------|
| 21 CFR Reference: | 872.3640 |
| 21 CFR Common Name: | Endosseous Dental Implant |
| Classification: | Class II |
| Panel: | Dental DZE |

#### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name: IMTEC Sendax MDI and MDI Plus, K031106 (8/12/2003) Trade/Proprietary Name: IMTEC MDI MII One-Piece Implant, 2.9mm, K08165 (9/19/2008)

#### D. DEVICE DESCRIPTION

Prismatik Dentalcraft, Inc.'s Inclusive® Mini Implant is a one-piece, root-form, screw-type, endosseous dental implant. These self-tapping, threaded implants are manufactured from Ti6Al-4V ELI, titanium alloy for surgical implant applications (ASTM F136). The Mini Implant will be available in 9 sizes: 2.2mm, 2.5mm, and 3.0mm diameters in 10mm, 13mm, and 15mm thread lengths. The implant body has a thread design for bone compression and the surface is blasted and etched to facilitate osseointegration. The 3.0mm implant has microthreads at the intra-osseous collar to preserve crestal bone. The Mini Implants have a transgingival collar 2mm in height and an O-Ball design prosthetic head.

### E. INDICATIONS FOR USE

Inclusive® Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive® Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional

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stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

#### F. SUBSTANTIAL EQUIVALENCE

The Inclusive® Mini Implants are substantially equivalent to the IMTEC Sendax MDI and MDI Plus and the IMTEC MDI Mil One-Piece Implant, 2.9mm. These devices are all one piece endosseous dental implants that are a combination of implant and abutment sections. All are made of titanium alloy commonly used for surgical implant applications. Also, the retention feature on the Inclusive® Mini Implant which retains the denture is identical to the predicate devices. The implants are intended for use in long-term and provisional applications. They all allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. All are provided STERILE.

| Element of | Prismatik's | IMTEC Sendax MDI | IMTEC MDI MII One- |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | Inclusive® Mini Implant | and MDI Plus | Piece Implant, 2.9mm |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Diameters (mm) | 2.2, 2.5, 3.0 | 1.8, 2.1, 2.4 | 2.9 |
| Lengths (mm) | 10, 13, 15 | 10, 13, 15, 18 | 10, 13, 15, 18 |
| Prosthetic Head | O-Ball | O-Ball, Square | O-Ball, Square |
| Driver | Square | Square | Square |
| Connection | | | |
| Housing/O-Ring | Titanium Alloy/EPDM | Titanium Alloy/EPDM | Titanium Alloy/EPDM |
| Indications | Inclusive® Mini Implants<br>are self-tapping threaded<br>titanium screws indicated<br>for long-term applications.<br>Inclusive® Mini Implants<br>may also be used for<br>provisional applications.<br>These devices will allow<br>immediate loading and<br>long-term stabilization of<br>dentures and provisional<br>stabilization of dentures<br>while standard implants<br>heal. To be used for<br>immediate loading only in<br>the presence of primary<br>stability and appropriate<br>occlusal loading. | The MDI and MDI PLUS are<br>self-tapping titanium<br>threaded screws indicated<br>for long-term intra-bony<br>applications. Additionally,<br>the MDI may also be used for<br>inter-radicular transitional<br>applications. These devices<br>will permit immediate<br>splinting stability and long-<br>term fixation of new or<br>existing crown and bridge<br>installations, for full or<br>partial endentulism, and<br>employing minimally invasive<br>surgical intervention. | The MII implant is intended<br>to support single or multi-<br>unit restorations in both<br>long-term and temporary<br>applications throughout<br>the maxillary and<br>mandibular arches. The<br>MII implant is indicated for<br>immediate loading when<br>good primary stability is<br>achieved. Additionally, this<br>device will permit stability<br>and long term fixation of<br>upper and lower dentures<br>in edentulous cases. |
| Sterility | STERILE | STERILE | STERILE |

#### G. PERFORMANCE DATA

The Inclusive® Mini Implants were subjected to verification and validation studies. This testing was conducted in accordance with the FDA Guidance for Industry and FDA Staff, Class II Special Controls Guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments issued May 12, 2004. The results of the testing demonstrate the Inclusive® Mini Implants are safe and effective for use.

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Testing included Static and fatigue strength, sterilization validation, bioburden, and shelf life validation, packaging integrity, cytotoxicity, and independent clinician evaluations.

.

# H. COMPARISON OF TECHNOLOGICAL DIFFERENCES

.

There are no known technological differences between the Inclusive® Mini Implants and those of the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Mr. Keith Allred Director, Professional Services Prismatik Dentalcraft, Incorporated 4141 Mac Arthur Boulevard Newport Beach, California 92660

DEC 2 7 2010

Re: K100932

Trade/Device Name: Inclusive Mini Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 13, 2010 Received: December 14, 2010

Dear Mr. Allred:

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 - Mr. Allred

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Anthony 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

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PRISMATIK DENTALCRAFT. INC Prismatik Dentalcraft, Inc. 4141 Mac Arthur Boulevard Newport Beach, CA 92660

#### INDICATIONS FOR USE STATEMENT

510(K) Number:

K100932

DEC 2 7 2010 -

Inclusive Mini Implant Device Name:

Indications for Use:

Inclusive Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.

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

Over-the-Counter Use _ (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rebekah L. Dr. S. Rumer

Hospita