(74 days)
Not Found
No
The summary describes a standard dental implant abutment and does not mention any AI or ML capabilities.
Yes
The device is a prosthetic component that aids in prosthetic rehabilitation, which is a therapeutic intervention.
No
The device is described as a premanufactured prosthetic component (an endosseous dental implant abutment) intended for prosthetic rehabilitation, not for diagnosing a condition.
No
The device description explicitly states that the device is made entirely of titanium or titanium/vanadium alloy, indicating it is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the NobelProcera Ti Abutments are "premanufactured prosthetic components directly connected to endosseous dental implants" and are intended for "prosthetic rehabilitation." They are physical components used within the body to support a dental restoration.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely mechanical and structural.
The information provided focuses on the physical properties, compatibility, and mechanical performance (fatigue testing) of the abutment, which are typical characteristics of a medical device intended for implantation or prosthetic use, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
NHA
Device Description
Nobel Biocare's NobelProcera Ti 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 Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.
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
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 quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 | AUG 31 2010 |
| Telephone: | (714) 282-5074 | |
| Facsimile: | (714) 998-9348 | |
| Date of Submission: | June 17, 2010 | |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary
or Model Name: | NobelProcera Ti Abutment Thommen Platforms | |
| Legally Marketed Devices: | Nobel Biocare - NobelProcera Ti Abutment (K091756)
Thommen Medical AG - SPI Easy 4.0 Abutment (K071457)
Thommen Medical AG - SPI Dental Implant Abutments (K031747) | |
Device Description:
Nobel Biocare's NobelProcera Ti 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 Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.
The abutments fit the Thommen SPI implant systems platform 3.5, 4.0, 4.5, 5.0, 6.0.
Indications for Use:
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.
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 quidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates That the device is safe and effective for its intended use and performs as well or better than the predicate devices.
Nobel Biocare Special 510(k) Notification NobelProcera Ti Abutments Thommen Platforms June 2010
1
Substantial Equivalence Comparison to Predicate Devices
など
| ATTRIBUTE | CANDIDATE | PREDICATE | PREDICATE | PREDICATE |
|---|---|---|---|---|
| Design/ | ||||
| construction | Nobel Procera Ti | |||
| Abutment | ||||
| Thommen Platforms | NobelProcera Ti Abutment | |||
| (K091756) | Thommen Medical AG | |||
| SPI Easy 4.0 Abutment | ||||
| (K071453) | Thommen Medical AG | |||
| SPI Dental Implant Abutments | ||||
| (K031747) | ||||
| Anatomical | ||||
| Site | Patient specific / machined |
Oral Cavity | Patient specific / machined
Oral Cavity | Patient specific / machined
Oral Cavity | Patient specific / machined
Oral Cavity |
| Platform
compatibility | Thommen
SPI implant systems platform
3.5, 4.0, 4.5, 5.0, 6.0 | Nobel Biocare
Brånemark NP, RP, WP
Replace NP, RP, WP, 6.0
Active NP, RP | Thommen
SPI implant systems platform
4.0 | Thommen
SPI implant systems platform
3.5, 4.5, 5.0, 6.0 |
| | | 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 | CP Titanium | CP Titanium |
| Indications for
Use | The Nobel Procera Ti
Abutments are
premanufactured prosthetic
components directly
connected to endosseous
dental implants and are
intended for use as an aid in
prosthetic rehabilitation. | The Nobel Procera Ti Abutments
are premanufactured prosthetic
components directly connected to
endosseous dental implants and
are intended for use as an aid in
prosthetic rehabilitation. | 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. | 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. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which features a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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 Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887
AUG 31 2010
Re: K101714
Trade/Device Name: NobelProcera Ti Abutment Thommen Platforms Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 2, 2010 Received: August 3, 2010
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.
3
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.
Wh for
Anthony D. 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
4
510(k) Number (if known): Klol 714
Device Name: NobelProcera Ti Abutment Thommen Platforms
Indications For Use:
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.
× 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)
Rei Mulley for HSR
(Division Sign-Off) Division of Anesthesiology, General Ho Infection Control, Dental Devices
000020 510(k) Number: K | 0 \ 7 | 4