AURADAPT AUBTMENT SYSTEM

K972475 · Nobel Biocare Uas, Inc. · NHA · Sep 12, 1997 · Dental

Device Facts

Record IDK972475
Device NameAURADAPT AUBTMENT SYSTEM
ApplicantNobel Biocare Uas, Inc.
Product CodeNHA · Dental
Decision DateSep 12, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3630
Device ClassClass 2
AttributesTherapeutic

Intended Use

Nobel Biocare's AurAdapt™ Abutment System is a set of screw retained modifiable gold alloy 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 by a screw or by dental cement to restore a patient's chewing function.

Device Story

AurAdapt Abutment System comprises modifiable gold alloy abutments, abutment screws, and associated laboratory/clinical tools (screwdrivers, impression copings, temporary cylinders). System used by dental professionals in clinical settings to restore patient chewing function. Abutments secure to endosseous dental implants via gold abutment screws. Components are modifiable via casting or wax-up techniques to support either screw-retained or cemented dental prostheses. Multi-unit bridges can be constructed using multiple abutments. Device acts as mechanical interface between implant fixture and final prosthetic restoration. Clinical benefit is restoration of masticatory function. Healthcare providers use device to anchor artificial teeth; proper seating and torque application are critical to prevent screw loosening, fracture, or gingival inflammation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.

Technological Characteristics

System consists of modifiable gold alloy abutments, gold abutment screws, and various laboratory/clinical accessories. Components are designed for mechanical attachment to endosseous dental implants. No electronic, software, or energy-based components. Sterilization is performed by the end-user (autoclavable components).

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants. Functions as an anchor for screw-retained or cement-retained prosthetic artificial teeth to restore chewing function.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 472475 Pre-market Notification Page -3-.............................................................................................................................................................................. SEP 1 2 1997 #### 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 modifiable gold alloy 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 including the UCLA - Type Abutments (K934495), CeraOne™ Abutment Screw (K961737), Guide Pin (K911969), Abutment Lab-Screw (K925769), CerAdapt™, Machine Counter Torque Device (K953775), EsthetiCone Temporary Cylinder (K925766), Miruscone Temporary Cylinder (K962403), Temporary Tube (K926766), Titanium Impression Coping (K952448), Plastic Impression Coping (K910611), CeraOne™ Screwdrivers (K922805) and Fixture Guide Set Tray (K944963). D. Description of Device The Nobel Biocare AurAdapt™ Abutment System is a set of modifiable gold alloy abutments which are secured directly to the dental fixtures using a gold abutment screw. These abutments (also referred to as "Gold Cylinder to Fixture" abutments) can be casted into a screw retained dental prosthesis or reshaped by wax-up techniques to anchor a cemented prosthesis. When more than one of the modifiable abutments are used, a multi-unit bridge can be attached to the abutments. {1}------------------------------------------------ ## E. Intended Use of the Device Nobel Biocare's AurAdapt™ Abutment System is a set of screw retained modifiable gold alloy 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 by a screw or by dental cement to restore a patient's chewing function. - F. Comparison of Technological Characteristics · The technological characteristics between the components of the AurAdapt Abutment System 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: - 1. 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; - seating of abutments resulting in gingival initial 3. improper inflammation and fistulae formation, both conditions resolve when proper seating of the abutment is accomplished. - occasional fracture of the abutment screw which is usually caused by বা poorly designed and/or fabricated restorations that creates overloads or cause's metal fatigue. {2}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 1 7 2010 Ms. Phuong Nguven Son Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Re: K972475 Trade/Device Name: Auradapt 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. {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 (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 Ruome 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 {4}------------------------------------------------ | 510(k) Number (if known): | K972475 | |---------------------------|---------| |---------------------------|---------| AurAdapt Abutment System Device Name: Indications For Use: Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy 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 chewing function. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa Concurrence of CDRH, Office of Device Evaluation (ODE) unner Division Sign-Off Division of Dental, Infection Cont and General Hospi 510(k) Number Prescription Use ﮯ (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)
Innolitics
510(k) Summary
Decision Summary
Classification Order
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