(198 days)
Not Found
No
The summary describes a standard dental implant abutment and does not mention any AI or ML capabilities.
No
The device is a prosthetic component (dental abutment) used for rehabilitation, not for treating or curing a disease or condition.
No
This device is a prosthetic component (an abutment for dental implants) used in rehabilitation, not for diagnosing diseases or conditions.
No
The device description explicitly states the device is an "endosseous dental implant abutment" made "entirely of titanium," indicating it is a physical hardware component.
Based on the provided information, 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 oral cavity, not a diagnostic test performed on biological samples outside the body.
- Device Description: The device is described as a premanufactured prosthetic component made of titanium, designed to attach to dental implants and provide a platform for restoration. This aligns with a medical device used for treatment or restoration, not diagnosis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely mechanical and restorative within the oral cavity.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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,
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
1.4 510(k) Summary of Safety and Effectiveness
| Submitted by: | Phuong Nguyen
Regulatory Affairs Manager | |
|----------------------------------------|----------------------------------------------------------------------------|-------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba 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 Proprietary
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
000019
1
Substantial Equivalence Comparison to Predicate Devices
| ATTRIBUTE | CANDIDATE | PREDICATE |
|---|---|---|
| NobelProcera Ti Abutment | ||
| Camlog Platforms | NobelProcera Ti Abutment | |
| (K091756) | ||
| Design/ construction | Patient specific / machined | Patient specific / machined |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Platform compatibility | Camlog | |
| K Series 3.3, 3.8, 4.3, 5.0, 6.0 | Nobel Biocare | |
| Brånemark NP, RP, WP | ||
| Replace NP, RP, WP, 6.0 | ||
| Active NP, RP | ||
| Astra Tech | ||
| Yellow, Aqua, Lilac | ||
| Straumann | ||
| Octagon 3.5, 4.8, 6.5 | ||
| Bone Level 3.3, 4.1/4.8 | ||
| BIOMET 3i | ||
| Internal 3.4, 3.75/4.0, 5.0, 6.0 | ||
| External 3.4, 4.1, 5.0, 6.0 | ||
| Device Material | CP Titanium | |
| Titanium/vanadium alloy | CP Titanium | |
| Titanium/vanadium alloy | ||
| 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. | The NobelProcera Ti Abutments are | |
| premanufactured prosthetic | ||
| components directly connected to | ||
| endosseous dental implants and are | ||
| intended for use as an aid in prosthetic | ||
| rehabilitation. |
Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Camlog Platforms August 2012 .
・
000020
.
2
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.
3
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
4
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 |
Page 1 of _1 _________________________________________________________________________________________________________________________________________________________________
316(k) Number:
000018