IMPLANT BAR
Device Facts
| Record ID | K120858 |
|---|---|
| Device Name | IMPLANT BAR |
| Applicant | Prismatik Dentalcraft, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Dec 6, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, 5.0mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.
Device Story
Inclusive® Implant Bridge Framework is a patient-specific, precision-milled titanium bridge framework; attaches to endosseous dental implants via titanium screws. Device customized based on patient-specific instructions and models; intended to be finished into a final dental prosthesis using standard laboratory materials. Used by dental professionals in clinical settings to restore chewing function in partially or totally edentulous patients. Provides structural support for prosthetic teeth; benefits patient by restoring oral function. Shipped non-sterile.
Clinical Evidence
Bench testing only. Performed static and fatigue testing per ISO 14801:2007 to evaluate mechanical strength and implant-abutment compatibility. Sterilization validated per ANSI-AAMI ST79-2006. No clinical data presented.
Technological Characteristics
Material: Ti-6Al-4V ELI alloy (ASTM F 136). Design: Precision-milled titanium bars. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile (validated for steam sterilization).
Indications for Use
Indicated for partially or totally edentulous patients requiring bridge frameworks to restore chewing function. Compatible with specific Nobel Biocare, Zimmer, Biomet 3i, Straumann, and Astra Tech implant systems.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). 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.)
Predicate Devices
Reference Devices
- Prismatik's Inclusive Mini Implant (K100932)
- Biomet 3i's CAM StructSure Precision Milled Bars (K080864)
Submission Summary (Full Text)
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K120858
## 005-510 (k) Summary-807.92(c)
# DEC 0 6 2012
This 510 (K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
#### SUMITTER INFORMATION A.
Company Name:
Company Address:
Prismatik Dentalcraft, Inc.
2212 Dupont Dr., Suite IJK Irvine, CA 92612
Company Phone:
Company FAX:
Primary Contact Person:
Secondary Contact Person:
Date Summary Prepared:
949-399-1940
949-553-0924
Armin Zehtabchi. (949) 225-1234
Marilyn Pourazar, (949) 225-1269
November 28, 2012
#### B. DEVICE IDENTIFICATION
Trade/Proprietary Name:
21 CFR Common Name:
21 CFR Reference:
Classification:
Product Code:
Panel:
Inclusive® Implant Bridge Framework
21 CFR 872.3630
Endosseous Dental Implant Abutment
Class II
NHA
Dental
#### C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:.
Nobel /Procera Implant Bridge-K091848, Biomet 3i-CAM StructSure Overdenture Bars-K101582
#### DEVICE DESCRIPTION D.
Inclusive® Implant Bridge Framework attaches to implants. The Implant Bridge Framework is intended to be finished into a dental prosthesis using standard laboratory materials. The Inclusive® Implant Bridge Framework is customized by
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following instructions and models specific to each patient.
The Inclusive® Implant Bridge Framework is made of titanium and shipped non-sterile. The Inclusive® Implant Bridge Framework will be attached with titanium screws.
#### E. INDICATION FOR USE
Indications for Use: The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, 5.0mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.
#### SUBSTANTIAL EQUIVALENCE F.
The Inclusive® Implant Bridge Framework is substantially equivalent to the Nobel /Procera Implant Bridge and Biomet 3i-CAM StructSure Overdenture Bars. The Inclusive® Implant Bridge Framework is substantially equivalent in indications for use, material, design and performance.
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| Callery Company of September 1998 to the states of the states of the states of the states of the states of the states of the states of the states of the states of the states | 1 |
Comparison of Predicate Devices
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| Elements of Comparison | Prismatik's Inclusive® Implant Bridge Framework | Nobel /Procera Implant Bridge-K091848 | Biomet 3i's CAM StructSure Overdenture Bars-K101582 | Prismatik's Inclusive Mini Implant-K100932 | Biomet 3i's CAM StructSure Precision Milled Bars-K080864 |
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| Material | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. |
| Indications | The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. | The Nobel Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. | The 3i Patient-Specific CAM StructSure® Precision Milled Bars are intended for use as an accessory to endosseous dental implant to support a prosthetic device in a partially or edentulous patient. | 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.Jo be used for immediate loading only in the presence of primary stability and appropriate occlusal loading. | The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained. |
| Design | Precision-milled bars made of titanium. | Precision-milled bars made of titanium. Design features and technological characteristics have been previously cleared for market (K091848). | Precision-milled bars made of titanium. Design features and technological characteristics have been previously cleared for market (K101582). | Precision-milled bars made of titanium. | Precision-milled bars made of titanium. |
| Performance | The titanium materials have sufficient mechanical strength for their indicated use. | Performance and technological characteristics have been previously cleared for market (K091848). | Performance and technological characteristics have been previously cleared for market (K101582). | The titanium materials have sufficient mechanical strength for their indicated use. | Performance and technological characteristics have been previously cleared for market (K0808864). |
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#### PERFORMANCE DATA G.
The following FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments was used for the purpose of Implant to Abutment Compatibility. Various static and fatigue tests were performed by following the ISO 14801: 2007- Dentistry - Implants -- Dynamic fatigue test for endosseous dental implants. All testing conducted met the acceptance criteria and evaluated the worst case scenario. Performance testing data indicated the compatibility, and the safety and the effectiveness of the proposed device which meets the mechanical properties. In addition, the sterilization tests were validated by following the ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Furthermore, the use of Titanium alloy as a material with acceptable performance for Inclusive® Implant Bridge Framework is well documented in the dental literature.
### COMPARISON OF TECHNOLOGICAL DIFFERENCES H.
There are no known technological differences between the Inclusive® Implant Bridge Framework and those of the predicate devices.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
## Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
## December 6, 2012
Ms. Kathleen Dragovich Manager, Regulatory Affairs / Quality Assurance Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K120858
Trade/Device Name: Inclusive® Implant Bridge Framework Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 16, 2012 Received: November 19, 2012
Dear Ms. Dragovich:
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. Iisting 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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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,
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. 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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## 004-Indications for Use Statement
510 (K) Number (if known): To be determined
Inclusive® Implant Bridge Framework Device Name:
Indications for Use: The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.
Prescription Use: Yes X No
Over-the-Counter Use: Yes |_ No X
(Part 21 CFR 801 Subpart D)
(Part 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)
2012.12.06 13:40:31 Susan Runner DDS, MA 2012.1
(Division Sign-Off)
Division of Anesthesiology, General Hospita,
Infection Control, Dental Devices
| 510(k) Number: | K120 858 |
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