(181 days)
Not Found
No
The summary describes a passive mechanical device (dental abutment) made of titanium alloys and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is an abutment for dental implants, used to support prostheses, and its function is structural rather than therapeutic (treating or preventing a disease).
No
Explanation: The device is an abutment for dental implants, used for prosthetic rehabilitation to support crowns, bridges, or overdentures. Its purpose is to provide structural support, not to diagnose a medical condition.
No
The device description explicitly states the device is comprised of titanium alloys, indicating it is a physical hardware component, not software.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "Inclusive Abutment" used in conjunction with dental implants to support prostheses (crowns, bridges, overdentures). It is a physical component used in a surgical and restorative procedure within the mouth.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its purpose is purely mechanical and structural.
Therefore, the Inclusive Abutment falls under the category of a dental prosthetic component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is indicated for use by dental technicians in the construction of custom made dental restorations that are supported by endosseous dental implants.
The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.
Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Product codes
NHA
Device Description
The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch (mouth)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063341, K072642, K042658, K022425, K041275, K061847, K071439
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
1073217
510(k) Summary
MAY 1 4 2008
Submitter: Inclusive Dental Solutions 4141 MacArthur Blvd. Newport Beach, CA 92660
Contact Person(s): Keith D. Allred, 949-440-2683 (phone) / 949-440-2787 (fax) and consultants, Greg Minzenmayer & Grant Bullis
Date of Application: October 21, 2007 (Revised April 22, 2008)
Device Name:
- · Trade Name Inclusive™ Implant Abutment
- · Common Name Endosseous dental implant abutments
- · Classification II
- · Product Code NHA
Description: The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.
Intended Use: The device is indicated for use by dental technicians in the construction of custom made dental restorations that are supported by endosseous dental implants.
Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439).
Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comperative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.
1
Image /page/1/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 overlapping wing-like shapes, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Mr. Keith D. Allred Official Correspondent Inclusive Dental Solutions 4141 MacArthur Boulevard Newport Beach, California 92660
Re: K073217
Trade/Device Name: Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 23, 2008 Received: April 15, 2008
Dear Mr. Allred:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 – Mr. Allred
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR, Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
CARS
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Schedule B
Indications for Use Statement
510(k) Number: K073217
Device Name: Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants
Indications for Use:
The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.
Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Prescription Use X (Part 21 CFR 801 SubpartD) AND/OR
Over-The-Counter Use (21 CFR 801 SubpartC)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runse
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC73217