(73 days)
Not Found
No
The summary describes a physical dental abutment system made of gold alloy, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an anchor for prosthetic devices, such as artificial teeth, to restore chewing function. It is a component of a dental restoration, not a therapeutic device meant to treat or cure a disease or condition.
No
This device is described as an abutment system intended to function as an anchor for prosthetic devices to restore chewing function, not to diagnose a condition.
No
The device description explicitly states it is a set of "modifiable gold alloy abutments," which are physical hardware components.
Based on the provided information, the Nobel Biocare AurAdapt™ Abutment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the AurAdapt™ Abutment System clearly states its purpose is to function as an anchor for prosthetic devices (artificial teeth) to restore chewing function. This is a mechanical and structural function within the body, not an examination of bodily specimens.
The device is a dental implant component used for restoring oral function, which falls under the category of medical devices, but not specifically IVD devices.
N/A
Intended Use / Indications for 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.
Product codes
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K934495, K961737, K911969, K925769, K953775, K925766, K962403, K926766, K952448, K910611, K922805, K944963
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
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:
-
- 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.
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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 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)