NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region.

Device Description

NobelActive Zirconia Abutments are artificial tooth abutments designed to fit and function on the NobelActive Implants. It is an internal hexagonal design similar to the previous SFB (renamed NobelActive) Abutments. The material of construction is the same as the previous Esthetic Zirconia Abutments. The NobelActive Zirconia Abutments differ from the predicate device in trade name and material of construction.

AI/ML Overview

This document is a 510(k) summary for a dental abutment, which is a physical device, not an AI/ML algorithm. Therefore, the questions regarding acceptance criteria, study data, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies for AI performance are not applicable.

The document describes the NobelActive Zirconia Abutment, a pre-manufactured prosthetic component intended for use in dental rehabilitation.

Here's the relevant information from the provided text, re-contextualized for a physical medical device:

Device Description:

Device Name: NobelActive Zirconia Abutment
Purpose: Artificial tooth abutment designed to fit and function on NobelActive Implants.
Design: Internal hexagonal design, similar to previous SFB (renamed NobelActive) Abutments.
Material: Same as previous Esthetic Zirconia Abutments.
Distinguishing Features (from predicate): Differs in trade name and material of construction from the predicate device.

Indications for Use:

"NobelActive Zirconia Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation in the anterior region."

Regulatory Information:

510(k) Number: K072129
Applicant: Nobel Biocare USA LLC
Predicate Devices: SFB & CFB Angled Abutments (K062749) and Esthetic Zirconia Abutment (K031719)
Classification: Class II, Endosseous Dental Implant Abutment (21 CFR 872.3630)

Study Information (as pertains to a physical device submission):

For physical medical devices like this, the "study" typically refers to demonstrating substantial equivalence to a predicate device through material characterization, mechanical testing, and biocompatibility assessments, rather than clinical performance studies with large patient cohorts and complex statistical analyses as would be common for new drugs or AI algorithms. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The provided text does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested for AI/ML algorithms (i.e., performance metrics, sample sizes for test/training, ground truth, expert opinions, etc.). Instead, the FDA's acceptance is based on the demonstration of substantial equivalence to existing predicate devices.

The submission would have included:

Comparison to Predicate: A comparison of the new device's technological characteristics (design, materials, indications for use) to the predicate devices.
Performance Data: This would typically include bench testing for mechanical properties (e.g., strength, fatigue, torque, fracture resistance) of the abutment and its connection to the implant, material characterization (e.g., chemical composition, microstructure), and possibly biocompatibility data. This data would be compared against established standards or performance levels of the predicate devices.
No "acceptance criteria table" or "reported device performance" in the AI/ML sense is present. The "performance" is implicitly deemed acceptable if it meets the criteria for substantial equivalence, ensuring it performs as intended and is as safe and effective as the predicates.

Without further documentation (e.g., the full 510(k) submission, which would detail the specific tests and their results), it's impossible to provide the granular "acceptance criteria" and "study data" in the AI/ML context.

Summary

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510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Kam Leung, Ph.D., RACSenior Regulatory Affairs Specialist
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7842
Facsimile:	(714) 282-9023
Date of Submission:	August 1, 2007
Classification Name:	Endosseous dental implant abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NobelActive Zirconia Abutment
Legally Marketed Device(s):	SFB & CFB Angled Abutments (K062749)Esthetic Zirconia Abutment (K031719)

Device Description:

Indications for Use:

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, positioned to the right. Encircling the symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

FEB 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K072129

Trade/Device Name: NobelActive Zirconia Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 8, 2008 Received: February 11, 2008

Dear Mr. Crane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Crane

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Shea Runser

Chiu Lin, Ph.D. 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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Indication for Use

510(k) Number (if known):

Device Name: NobelActive Zirconia Abutment

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 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 Quapp

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

Nobel Biocare Traditional 510(K) Not NobelActive Zirconia Abutment August 2007

000008

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.)