Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant abutment and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is described as a premanufactured prosthetic component and an aid in prosthetic rehabilitation, attaching to dental implants to provide a platform for restoration. It does not actively treat or cure a disease or condition.

Diagnostic

No

The provided text describes the NobelProcera Zi Abutments Thommen Platforms as premanufactured prosthetic components intended for use in prosthetic rehabilitation. Its function is to attach to dental implants and provide a platform for restoration. There is no mention of it being used to diagnose conditions, diseases, or provide any diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical component made of zirconium oxide (an endosseous dental implant abutment) and describes non-clinical testing related to fatigue of this physical component. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "prosthetic rehabilitation" by connecting directly to dental implants. This is a mechanical function within the body, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is described as a "premanufactured prosthetic component" and an "endosseous dental implant abutment." These are physical components used in a surgical and restorative procedure.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition

The device is clearly a medical device used in a dental procedure, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NobelProcera Zi Abutments Thommen 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 Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Product codes

NHA

Device Description

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

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

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101714, K071457, K031747

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.)

Summary

0

K110171

JUN 15 2011

510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Herbert Crane
Director, Global Regulatory Affairs |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | January 13, 2011 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary
or Model Name: | NobelProcera Zi Abutment Thommen Platforms |
| Legally Marketed Devices: | Nobel Biocare - NobelProcera Ti Abutment Thommen Platforms
(K101714)
Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)
Thommen Medical AG - SPI Dental Implant Abutments (K031747) |

Device Description

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

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

The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.

Indications for Use

The NobelProcera Zi Abutments Thommen 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 Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

Technical Modifications of Predicate Device

The NobelProcera Zi Abutment for the Thommen Platform differs from the predicates by using the material zirconium oxide.

Nobel Biocare Special 510(k) Notification NobelProcera Zi Abutments Thommen Platforms January 2011

1

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 analysis of platforms to identify worst-case test samples and performance of fatigue testing of the worst-case samples 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 devices.

Nobel Biocare Special 510(k) Notification NobelProcera Zi Abutments Thommen Platforms January 2011

2

ubstantial Equivalence Comparison to Predicate Devices

ATTRIBUTE	CANDIDATE	PREDICATE	PREDICATE
Design/
Construction	NobelProcera Zi
Abutment
Thommen Platforms	NobelProcera Ti Abutment
Thommen Platforms
(K101714)	Thommen Medical AG
SPI Dental Implant Abutments
(K031747)
Anatomical
Site	Patient specific / machined	Patient specific / machined	Patient specific / machined
Platform
Compatibility	Oral Cavity	Oral Cavity	Oral Cavity
Device
Material	Thommen
SPI implant systems platform
3.5, 4.0, 4.5, 5.0, 6.0	Thommen
SPI implant systems platform
3.5, 4.5, 5.0, 6.0	Thommen
SPI implant systems platform
3.5, 4.5, 5.0, 6.0
Indications for
Use	Zirconium Oxide	CP Titanium
Titanium/vanadium alloy
The NobelProcera Ti Abutments
Thommen 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 Thommen
Medical SPI 3.5, 4.0, 4.5, 5.0, and
6.0 implants.	CP Titanium
The Thommen SPI Easy 4.0
Abutment is intended to be used
in conjunction with SPI System
dental implants in the maxillary
and/or mandibular arch to
provide support for crowns,
bridges or overdentures.	CP Titanium
The Thommen SPI Dental Implant
Abutments are intended to be
used in conjunction with SPI
System dental implants in the
maxillary and/or mandibular arch
to provide support for crowns,
bridges or overdentures.

3

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

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

JUN 1 5 2011

Re: K110171

Trade/Device Name: NobelProcera Zi Abutment Thommen Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 13, 2011 Received: May 16, 2011

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. 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.

4

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); 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,

for

Anthony 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

5

Indications for Use

KIIO17 | 510(k) Number (if known):

Device Name: NobelProcera Zi Abutment Thommen Platforms

Indications For Use:

The NobelProcera Zi Abutments Thommen 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 Thommen Medical SPI 3.5, 4.0, 4.5, 5.0, and 6.0 implants.

× 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)

Robert S. Betz, DDS for Dr. Susan Runner

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

Page 1 of 1

510(k) Number: K110171

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