The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.

Device Description

The Angled Tapered Abutment has an external hex which engages the hex of the Tapered Screw-Vent and Screw-Vent implant. The abutments are available in multiple cuff heights and in both 15° and 30° configurations to provide angulation correction for off-angle implant placement. The abutment is secured to the implant with an abutment retaining screw. The abutment screw is preassembled in the abutment and is not removable from the abutment. The abutment has a tapered cone with an internal screw access for the attachment of various restorative components using a separate coping screw. The abutment cone has a 15° taper and is 1.2mm tall. Abutments are packaged with a metal delivery tool to assist with the placement and orientation of the abutment into the implant. The abutment and abutment retaining screw are fabricated from titanium allov.

The current tapered abutments facilitate multiple-unit, screw-retained restoration. These abutments do not engage the internal hex.connection. and are not for use in single-unit. While the current tapered abutments are somewhat limited to straight restoration, the new device will expand the functionality of our screw retained restoration by permitting angled restoration. It will be available in titanium 6Al-4V and will provide an angulation up to 30°.

AI/ML Overview

The Angled Tapered Abutment is a dental device intended for use as a terminal or intermediate abutment in screw-retained multiple-unit restorations. The acceptance criteria and the study conducted to demonstrate the device's performance are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical Performance: The device must demonstrate sufficient strength and integrity to withstand anticipated forces encountered in the oral environment. This includes resistance to fatigue and compression. Results are expected to be comparable to or better than predicate devices. | Achieved: Non-clinical testing, including fatigue and compression testing, was performed in accordance with FDA guidance "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." The testing "indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device." |
| Material Equivalence: The device material must be equivalent to predicate devices for biocompatibility and mechanical properties. | Achieved: The Angled Tapered Abutment is fabricated from Titanium 6Al-4V, which is the same material as the predicate NobelActive Multi Unit Abutment and Tapered Abutment. |
| Implant/Abutment Connection Equivalence: The connection mechanism between the abutment and implant should be equivalent to predicate devices to ensure proper fit and function. | Achieved: The Angled Tapered Abutment's method of attachment (internal screw threaded through internal hex into implant) is equivalent to both predicate devices. |
| Abutment Platforms Equivalence: The available abutment platforms should be comparable to existing devices to maintain compatibility with restorative components. | Achieved: The new device offers 3.5, 4.5mm platforms, which are comparable to the 3.5, 3.9mm of Predicate No. 1 and 3.5, 4.5, 5.7mm of Predicate No. 2. |
| Angulation Capability: The device must provide the specified angulation correction (15° and 30° configurations) for off-angle implant placement. | Achieved: The device is available in 15° and 30° configurations, providing angulation up to 30°, similar to Predicate No. 1. Predicate No. 2 had 0° angulation. |

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific non-clinical tests. The document indicates that "Non-clinical test data was used," implying a sufficient number of samples were tested to meet the guidance. Specific quantities for each test (e.g., number of abutments for fatigue testing) are not detailed.
Data Provenance: The data is from non-clinical testing performed by Zimmer-Dental-Inc. within the United States. It is prospective testing, as it was conducted specifically to gather performance data for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is Not Applicable as the study did not involve human experts establishing ground truth. The acceptance criteria were based on objective engineering and material performance standards (e.g., strength, material composition) and compliance with regulatory guidance.

4. Adjudication Method for the Test Set

This section is Not Applicable as the study involved objective non-clinical testing against predefined engineering standards, rather than human review or adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is Not Applicable. The study describes the performance of a physical dental abutment and does not involve AI, human readers, or clinical imaging.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is Not Applicable, as the device is a physical dental abutment, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by established engineering standards and regulatory guidance documents. Specifically, performance tests were conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." This guidance provides objective criteria and methodologies for assessing the safety and effectiveness of such devices.

8. The Sample Size for the Training Set

This section is Not Applicable. The study involves physical device testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This section is Not Applicable, as there was no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside it. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and the word "dental" is written in a smaller, serif font below a horizontal line.

Zimmer Dental
---------------	--

1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph)

760.431.7811 (fax)

< 111 857 510k No .:

A5-1 Page No .:

DEC - 8 2011

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

510(k) SUMMARY (21CFR807.92(a))

Submitter's Information: 1.

Name:	Zimmer-Dental-Inc.
Address:	1900 Aston Ave. Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Melissa Burbage

Date Prepared: June 27, 2011

2. Device Name:
-----------------

Trade Name:	Angled Tapered Abutment
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Endosseous Dental Implant Abutment

1. Predicate Device(s):
  Predicate Device No. 1 NobelActive Multi Unit Abutment Trade Name: Requlation Number: 872.3630 Classification Code: NHA Endosseous Dental-Implant Abutment Device Classification-Name:

Predicate Device No. 2 Tapered Abutment Trade Name: 872.3630 Regulation Number: NHA Classification Code: Endosseous Dental Implant Abutment Device Classification Name:

Device Description: 4.

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Angled Tapered Abutment

510(k) No. K111853
Page No. A5-2

and is not removable from the abutment. The abutment has a tapered cone with an internal screw access for the attachment of various restorative components using a separate coping screw. The abutment cone has a 15° taper and is 1.2mm tall. Abutments are packaged with a metal delivery tool to assist with the placement and orientation of the abutment into the implant. The abutment and abutment retaining screw are fabricated from titanium allov.

ട. Indications for Use:

6. Device Comparison:

The Angled Tapered Abutment is substantially equivalent to the predicate NobelActive Multi Unit Abutment in the material, implant/abutment connection, abutment platforms and angulations. The Angled Tapered Abutment is substantially equivalent to the predicate Tapered Abutment in the material, implant/abutment connection, abutment platforms, and mating of prosthetic components.

Technological Characteristics 7.

Feature	New Device 1Angled Tapered Abutment	Predicate No. 1Nobel Active Multi Unit Abutment	Predicate No. 2Tapered Abutment
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V
Abutmentangles	Up to 30°	Up to 30°	0°
Platforms	3.5, 4.5mm	3.5, 3.9mm	3.5, 4.5, 5.7mm
Method ofAttachment	Internal screw threadedthrough internal hex intoimplant	Internal screw threadedthrough internal hex intoimplant	Internal screw threadedthrough internal hex intoimplant

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510(k) No.	K111853
Page No.	A5-2

8. Non-Clinical Testing:

Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements-over-the-predicate-device.--------------------------------------------------------------------------------------------------------------------------

ல் Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.

10. Conclusion

Based on our analysis, the device is substantially equivalent to the predicate and considers the new device is as safe and effective for its intended use and performs as well or better than the predicate device.

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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

DEC - 8 2011

Ms. Melissa Burbage Regulatory Affairs Manager Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008

Re: K111853

Trade/Device Name: Angled Tapered Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2011 Received: December 1, 2011

Dear Ms. Burbage:

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. Burbage

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

hh for

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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Indications for Use

510(k) Number (if known): << < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

Device Name: Angled Tapered Abutment

Indications For Use:

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

Over-The-Counter Use (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)

Susan Rurr
Division Sign Off)

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

510(k) Number: K-111853

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)