(80 days)
Nobel Biocare's Procera Abutment System is a set of screw retained preparable abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chowing function.
The Nobel Biocare Procera® Preparable Abutment System is comprised of a titanium abutment which is secured to the Branemark System® dental implants with a gold abutment screw. This system functions as an anchor to which a single crown can be cemented. When more than one preparable abutment is used, a multi-unit bridge can be cemented to the abutments. The Procera® Preparable Abutment also includes a counter torque device and adaptors, temporary cylinders, impression copings and machine Uni-grip screwdrivers.
This document does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) premarket notification for a dental abutment system.
Here's what the provided text does contain:
- Device Name: Nobel Biocare Procera® Preparable Abutment System
- Manufacturer: Nobel Biocare USA, Inc.
- Predicate Device: TiAdapt Abutments (K971706) and other existing components from Nobel Biocare's Branemark System®.
- Device Description: A system of titanium abutments, screws, counter torque devices, temporary components, and impression copings, designed to anchor single crowns or multi-unit bridges to dental implants.
- Intended Use: To function as an anchor for prosthetic devices (artificial teeth) to restore chewing function.
- Safety and Effectiveness Concerns (Identified with similar abutment systems): Occasional screw fractures due to overload, loose screws leading to granulation tissue/infection, improper seating causing gingival inflammation/fistulae, and abutment screw fracture from poorly designed restorations.
- Regulatory Information: Classified as an Endosseous Dental Implant Abutment (21 CFR 872.3630), Class II, product code NHA.
It does NOT include:
- A table of acceptance criteria or reported device performance.
- Details about a specific study (sample size, data provenance, expert involvement, adjudication, etc.) to demonstrate meeting acceptance criteria.
- Information on a multi-reader multi-case (MRMC) study or standalone algorithm performance.
- Details regarding training set size or its ground truth establishment.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing new clinical trials with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) might require. The "Summary of Safety and Effectiveness Concerns" in this document refers to known issues with similar devices, not specific performance metrics of the submitted device.
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Pre-market Notification Page -3-*****************************************************************************************************************************************************************************
JAN 2 3 1998
510(k) Summary of Safety and Effectiveness VII.
A. Name and Address
This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. The telephone number is: (630) 654-9100, extension 2002, and the contact person will be Betsy Brown, the Vice President, Regulatory Affairs.
B. Name of the Device
This device system consists of various preparable titanium abutments, abutment screws, a counter torque device with handle, adaptors, machine Uni-grip screwdrivers with autoclavable box, temporary cylinders, temporary tubes, laboratory screws and impression copings.
C. The Predicate Product
The predicate products used in this Pre-market Notification are similar components marketed by Nobel Biocare which include the TiAdapt Abutments (K971706). However, the following devices are existing products that have been "cleared" for their indicated use under 510K #971706 for TiAdapt. These components are to be used as specified in the "Clinical Procedure" which is presented in Exhibit B. The components include the following: Abutment Screws Uni-Grip, Laboratory-Screws, Counter Torque Device, Counter Torque Device Adaptors, Counter Torque Instrument Tray, Temporary Cylinders, Temporary Tubes, Impression Copings, Impression Coping Screws, Plastic Impression Coping and Machine Uni-Grip Screwdriver.
D. Description of Device
The Nobel Biocare Procera® Preparable Abutment System is comprised of a titanium abutment which is secured to the Branemark System® dental implants with a gold abutment screw. This system functions as an anchor to which a single crown can be cemented. When more than one preparable abutment is used, a multi-unit bridge can be cemented to the abutments. The Procera® Preparable Abutment also includes a counter torque device and adaptors, temporary cylinders, impression copings and machine Uni-grip screwdrivers.
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E. Intended Use of the Device
Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.
F. Comparison of Technological Characteristics
The technological characteristics between the components of the Procera® Preparable Abutment and the corresponding predicate products found in the Branemark System® are identical.
Summary Of Safety And Effectiveness Concerns
Safety and effectiveness problems that have been encountered with similar Abutment Systems used with endosseous implants that are currently being marketed include:
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- occasional fractures of the screw attaching the abutment to the fixtures usually due to functional overload from masticastory forces;
- loose (usually because torque force below 2. screws working recommended values was applied when the abutment was attached to the fixture) may lead to the formation of granulation tissue at the level of the fixture and abutment connection which may, in turn, result in infection;
- initial seating of abutments resulting in gingival 3. improper inflammation and fistulae formation, both conditions resolve when proper seating of the abutment is accomplished.
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- occasional fracture of the abutment screw which is usually caused by poorly designed and/or fabricated restorations that creates overloads or cause's metal fatigue.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 7 2010
Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Way Parkway Yorba Linda, California 92887
Re: K974150
Trade/Device Name: Procera Preparable Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2010 Received: July 29, 2010
Dear Ms. Nguyen Son:
This letter corrects our substantially equivalent letter of July 28, 2010.
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 (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.
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 (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Kuares
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
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510(k) Number (if known):
Device Name: Procera® Abutment System
Indications For Use:
Nobel Biocare's Procera Abutment System is a set of screw retained preparable abutments which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chowing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Praser | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974150 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
§ 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.)