The NobelProcera Ti Abutments Camlog Platforms are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0 and 6.0 implants.

Device Description

Nobel Biocare's NobelProcera Ti Abutment Camlog Platforms is an endosseous dental implant abutment. The abutment attaches directly to Camlog dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium.

The abutments are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants,

AI/ML Overview

This document describes the NobelProcera Ti Abutment Camlog Platforms, a premanufactured prosthetic component for dental implants. The information provided focuses on the regulatory submission (510(k)) and its basis for demonstrating safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

The device is a direct comparator to a legally marketed predicate device (Nobel Biocare - NobelProcera Ti Abutment (K091756)). The acceptance criteria for this type of device are primarily based on demonstrating substantial equivalence to the predicate, particularly concerning design, materials, and mechanical performance. The study conducted was non-clinical fatigue testing.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance/Findings
Design/Construction	Patient-specific / machined, similar to predicate	Matches Predicate: Patient specific / machined
Anatomical Site	Oral Cavity, similar to predicate	Matches Predicate: Oral Cavity
Device Material	CP Titanium, Titanium/vanadium alloy, similar to predicate	Matches Predicate: CP Titanium, Titanium/vanadium alloy
Indications for Use	Premanufactured prosthetic components, directly connected to endosseous dental implants, aid in prosthetic rehabilitation. Specific compatibility with Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants.	Substantially Equivalent with Specificity: The indications are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use as an aid in prosthetic rehabilitation. The key difference from the predicate is the specific compatibility listed for Camlog K series implants (3.3, 3.8, 4.3, 5.0, 6.0), which differentiates it from the predicate's broader compatibility with Nobel Biocare, Astra Tech, Straumann, and BIOMET 3i implants. This specificity is a design difference, not a divergence from the fundamental intended use.
Mechanical Performance	Fatigue testing in accordance with FDA guidance "Class II, Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."	Met Standard: Non-clinical test data for fatigue testing was used to support the decision of safety and effectiveness, indicating the device performed acceptably under the specified guidance. The submission concludes that this demonstrates substantial equivalence.

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

The document does not specify a "test set" in the context of human data or AI model evaluation. The study involved non-clinical performance of fatigue testing of the abutment. The sample size for this engineering testing is not explicitly stated but would typically involve multiple units to establish statistical confidence in the mechanical properties. The data provenance is non-clinical laboratory testing, not human data from a specific country.

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

This information is not applicable as the study was non-clinical fatigue testing, not a human reader study or clinical trial requiring ground truth established by medical experts.

4. Adjudication Method for the Test Set

This information is not applicable as the study did not involve human interpretation or a "test set" in the context of diagnostic performance that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on the substantial equivalence of a medical device (dental implant abutment) primarily through non-clinical mechanical testing, rather than evaluating the diagnostic or interpretative performance of human readers with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical device (dental implant abutment), not an AI algorithm. Therefore, no standalone algorithm performance study was done.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through engineering standards and physical measurements from the fatigue testing, as dictated by the FDA guidance for endosseous dental implants and abutments. It is not an expert consensus, pathology, or outcomes data in the usual sense of clinical studies.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable as the device is a physical medical device, not an AI model.

Summary

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K122602

1.4 510(k) Summary of Safety and Effectiveness

Submitted by:	Phuong NguyenRegulatory Affairs Manager
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887	MAR 13 2013
Telephone:	(714) 282-4800 x7830
Facsimile:	(714) 998-9348
Date of Submission:	August 24, 2012
Classification Name:Pro Code:	Endosseous Dental Implant Abutment (21 CFR 872.3630)NHA
Trade or Proprietaryor Model Name:	NobelProcera Ti Abutment Camlog Platforms
Legally Marketed Devices:	Nobel Biocare - NobelProcera Ti Abutment (K091756)

Device Description:

Nobel Biocare's NobelProcera Ti Abutment Camlog Platforms is an endosseous dental implant abutment. The abutment attaches directly to Camlog dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium.

The abutments are compatible with the Camlog K series 3.3, 3.8, 4.3, 5.0, 6.0 implants,

Indications for Use:

Summary of testing to demonstrate safety and effectiveness

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II, Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Conclusion

The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device.

Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Camlog Platforms August 2012

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Substantial Equivalence Comparison to Predicate Devices

ATTRIBUTE	CANDIDATE	PREDICATE
	NobelProcera Ti AbutmentCamlog Platforms	NobelProcera Ti Abutment(K091756)
Design/ construction	Patient specific / machined	Patient specific / machined
Anatomical Site	Oral Cavity	Oral Cavity
Platform compatibility	CamlogK Series 3.3, 3.8, 4.3, 5.0, 6.0	Nobel BiocareBrånemark NP, RP, WPReplace NP, RP, WP, 6.0Active NP, RPAstra TechYellow, Aqua, LilacStraumannOctagon 3.5, 4.8, 6.5Bone Level 3.3, 4.1/4.8BIOMET 3iInternal 3.4, 3.75/4.0, 5.0, 6.0External 3.4, 4.1, 5.0, 6.0
Device Material	CP TitaniumTitanium/vanadium alloy	CP TitaniumTitanium/vanadium alloy
Indications for Use	The NobelProcera Ti AbutmentsCamlog Platforms arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for use as an aid inprosthetic rehabilitation. They arecompatible with the Camlog Kseries 3.3, 3.8, 4.3, 5.0 and 6.0implants.	The NobelProcera Ti Abutments arepremanufactured prostheticcomponents directly connected toendosseous dental implants and areintended for use as an aid in prostheticrehabilitation.

Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Camlog Platforms August 2012 .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

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

March 13, 2013

Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, Limited Liability Company 22715 Savi Ranch Parkway YORBA LINDA CA 92887

Re: K122602

Trade/Device Name: NobelProcera Ti Abutment Camlog Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 5, 2013 Received: March 7, 2013

Dear Ms. Nguyen Son:

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. Nguyen Son

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 (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.

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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Indications for Use

510(k) Number (if known): KIZZ 602

Device Name: NobelProcera Ti Abutment Camlog Platforms

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Mary S. Runner -S
Susan Runner, DDS, MA	2013.03.13
	12:30:29 -04'00'

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Intervention Control, Dental Devices
	K122602

Page 1 of _1 _________________________________________________________________________________________________________________________________________________________________

316(k) Number:

000018

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.)