NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS

K122602 · Nobel Biocare AB · NHA · Mar 13, 2013 · Dental

Device Facts

• Record ID: K122602
• Device Name: NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Mar 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

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 Story

NobelProcera Ti Abutment Camlog Platforms are patient-specific, machined endosseous dental implant abutments; fabricated from CP titanium or titanium/vanadium alloy. Device connects directly to Camlog K series dental implants to provide a platform for prosthetic restoration. Used in clinical dental settings by trained dental professionals. Output is a physical prosthetic interface; facilitates attachment of dental crowns or bridges to implants. Benefits include patient-specific fit for prosthetic rehabilitation.

Clinical Evidence

Bench testing only. Fatigue testing performed in accordance with FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. No clinical data required.

Technological Characteristics

Materials: CP Titanium, Titanium/vanadium alloy. Form factor: Patient-specific, machined abutment. Connectivity: None (mechanical interface). Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring dental implant restoration. Compatible with Camlog K series 3.3, 3.8, 4.3, 5.0, and 6.0 implants.

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

• NobelProcera Ti Abutment (K091756)

Submission Summary (Full Text)

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K122602

#### 1.4 510(k) Summary of Safety and Effectiveness

| Submitted by: | Phuong Nguyen<br>Regulatory Affairs Manager | |
|----------------------------------------|----------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | MAR 13 2013 |
| Telephone: | [phone] x7830 | |
| Facsimile: | [phone] | |
| Date of Submission: | August 24, 2012 | |
| Classification Name:<br>Pro Code: | Endosseous Dental Implant Abutment (21 CFR 872.3630)<br>NHA | |
| Trade or Proprietary<br>or 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:

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.

### 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 Abutment<br>Camlog Platforms | NobelProcera Ti Abutment<br>(K091756) |
| Design/ construction | Patient specific / machined | Patient specific / machined |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Platform compatibility | Camlog<br>K Series 3.3, 3.8, 4.3, 5.0, 6.0 | Nobel Biocare<br>Brånemark NP, RP, WP<br>Replace NP, RP, WP, 6.0<br>Active NP, RP<br>Astra Tech<br>Yellow, Aqua, Lilac<br>Straumann<br>Octagon 3.5, 4.8, 6.5<br>Bone Level 3.3, 4.1/4.8<br>BIOMET 3i<br>Internal 3.4, 3.75/4.0, 5.0, 6.0<br>External 3.4, 4.1, 5.0, 6.0 |
| Device Material | CP Titanium<br>Titanium/vanadium alloy | CP Titanium<br>Titanium/vanadium alloy |
| Indications for Use | The NobelProcera Ti Abutments<br>Camlog Platforms are<br>premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and are<br>intended for use as an aid in<br>prosthetic rehabilitation. They are<br>compatible with the Camlog K<br>series 3.3, 3.8, 4.3, 5.0 and 6.0<br>implants. | The NobelProcera Ti Abutments are<br>premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and are<br>intended for use as an aid in prosthetic<br>rehabilitation. |

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 [phone] or [phone] 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:

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.

× 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 |

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316(k) Number:

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