MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM

K121688 · Prismatik Dentalcraft, Inc. · NHA · Oct 12, 2012 · Dental

Device Facts

• Record ID: K121688
• Device Name: MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Device Story

Prosthetic components for endosseous dental implants; provide support and retention for multi-unit screw-retained restorations. Abutments feature 17° or 30° angulations to correct off-angle implant placement. Fabricated from titanium 6Al-4V alloy; secured to implants via abutment retaining screw. Used by dental clinicians in clinical settings. Device facilitates multi-unit restoration by allowing for angulation correction, enabling splinted restorations within specified parallelism constraints. Provided sterile via gamma radiation in glass vials.

Clinical Evidence

Bench testing only. Analysis of platforms identified worst-case test samples; performance evaluated per FDA guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'. Results demonstrated safety and effectiveness comparable to the predicate device.

Technological Characteristics

Material: Titanium 6Al-4V alloy. Design: Multi-unit abutments with 17° and 30° angulations; internal hex connection. Platforms: 3.5mm and 4.5mm. Sterilization: Gamma radiation. Packaging: Glass vials in Chevron pouches.

Indications for Use

Indicated for patients requiring support and retention for multi-unit screw-retained dental restorations. Contraindicated for use outside of specified parallelism limits (30-degree abutments > 45 degrees; 17-degree abutments > 32 degrees).

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

• Zimmer Dental Angled Tapered Abutment (K111853)

Submission Summary (Full Text)

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K121688

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B.

# OCT 1 2 2012

### 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.

### SUBMITTER INFORMATION A.

Prismatik Dentalcraft, Inc. Company Name: Company Name 2212 Dupont Dr., Suite P. Company Address: Irvine, CA 92612 Company Phone: [phone] Company FAX: Armin Zehtabchi, [phone] Contact Person: Kathleen Dragovich, [phone] Date Summary Prepared: October 9, 2012 DEVICE IDENTIFICATION Trade/Proprietary Name: Multi-Unit Abutments with Angulations 17° and 30° for InclusiveTapered Implant System 21 CFR Reference: 21 CFR 872.3630 21 CFR Common Name: Endosseous Dental Implant Abutment Classification: Class II

Dental NHA Panel:

### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

Zimmer Dental Angled Tapered Abutment (K111853)

#### D. DEVICE DESCRIPTION

The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH.

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The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°.

K121688

The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.

#### E. INDICATIONS FOR USE

Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

#### F. SUBSTANTIAL EQUIVALENCE

The Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853). These abutments are substantially equivalent in intended use, indication for use, material, design and performance.

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## Comparison of Predicate Devices

| Elements of<br>Comparison | Prismatik's<br>Multi-Unit Abutments with<br>Angulations 17° and 30° for<br>Tapered Implant System | Zimmer Dental Angled<br>Tapered Abutment<br>(K111853) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium | Titanium |
| Indications | Inclusive Multi-Unit Abutments<br>are prosthetic components<br>directly connected to endosseous<br>dental implants and intended to<br>provide support and retention for<br>multi-unit screw-retained<br>restorations. The 30-degree<br>multi-unit abutments must be<br>used within 45 degrees of<br>parallelism for a splinted<br>restoration. The 17-degree<br>multi-unit abutments must be<br>used within 32 degrees of<br>parallelism for a splinted<br>restoration. | The Angled Tapered<br>Abutment is used for a<br>terminal or intermediate<br>abutment for screw-retained<br>multiple-unit restorations.<br>The 30Angled<br>Tapered Abutment must be<br>used within 45 degree of<br>parallelism for a<br>splinted restoration. The<br>15S0Angled Tapered<br>Abutment must be used<br>within 30 degrees of<br>parallelism for a splinted<br>restoration. |
| Abutment Angels | Up to 30° | Up to 30° |
| Platforms | 3.5, 4.5mm | 3.5, 4.5mm |
| Method of<br>Attachment | Internal screw threaded through<br>internal hex into implant | Internal screw threaded<br>through internal hex into<br>implant |

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### NON-CLINICAL TESTING G.

Non-clinical test data was used to support the decision of safety and effectiveness.

Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicated that the device is safe and effective for its intended use and performed as well or better than the predicate device.

#### H. CONCLUSION

The information provided in the submission demonstrates that the Multi-Unit Abutments for Angulations 17° and 30° for Inclusive Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 12 2012

Ms. Kathleen Dragovich Manager, Regulatory Affairs/Quality Assurance Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P Irvine, California 92612

Re: K121688

Trade/Device Name: Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System

Regulation Number: 21 CFR 872.3630

Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA

Dated: August 22, 2012

Received: August 27, 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, 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. Dragovich

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

signature

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 .

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### 004-Indications for Use Statement

510 (K) Number (if known): To be determined

Multi-Unit Abutments with Angulations 17° and 30° for Device Name: Tapered Implant System

Indications for Use: Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

Prescription Use: Yes No No (Part 21 CFR 801 Subpart D)

Over-the-Counter Use: Yes | No > (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)

Susan Suarez

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: