(255 days)
Not Found
No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implant system to restore chewing function by supporting dental prostheses, which addresses a medical condition or function.
No
This device is described as an implant system for supporting dental prostheses, not a tool for diagnosis or evaluation of a medical condition.
No
The device description clearly states it is a physical implant made of titanium, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a dental implant system intended for surgical implantation in the jawbone to support dental prostheses. This is a surgically implanted device, not a device used to test samples outside the body.
The information provided focuses on the physical characteristics, materials, intended anatomical location, and performance testing related to the mechanical and biological integration of the implant within the body. This is consistent with a medical device intended for implantation, not an IVD.
N/A
Intended Use / Indications for Use
The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The I Macro 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular molar region
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, pull-out testing, and static and dynamic compression-bending testing according to ISO 14801.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OCO Biomedical, I Macro Implant System, K110337, OCO Biomedical, TSI & ERI, K090174, "O" Company, Inc., Immediate Stabilizing Implant (ISI), K033392, "O" Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336, Implant Direct, LLC, Spectra Dental Implant System, K061319, Southern Implants, Inc., Endosseous Dental Implant System, K071161, Megagen Implant Company, LTD, Rescue External Implant System, K081302, Astra Tech AB, Astra Tech Implant System, K101732, Bicon, Inc., 6.0 x 5.7mm Dental Implant, K010185, Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035, Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368, Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044, Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mm Dental Implant, K050712, Bicon, Inc., The 5.0.x 6.0mm Dental Implant, K042637
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
1 Macro 6.0mm X 6.0mm
510(k) Summary
APR 0 5 2013
510(k) Summary OCO Biomedical, Inc. I Macro 6.0mm X 6.0mm K122198
April 3, 2013
ADMINISTRATIVE INFORMATION
| Manufacturer Name | OCO Biomedical, Inc. |
|---|---|
| 9550 San Mateo Blvd. NE, Suite C | |
| Albuquerque, NM 87113 | |
| Telephone: | +1 (505) 293-0025 |
| Fax: | +1 (505) 293-0447 |
| Official Contact | David D. Dalise D.D.S. |
David D. Dalise D.D.S. President/ Owner
Representative/Consultant
Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: LSchulz@paxmed.com FLarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name Common Name Classification Name Classification Regulation Product Code Classification Panel Reviewing Branch
I Macro 6.0mm X 6.0mm Implant Dental implant Implant, endosseous, root form Class II, 21 CFR 872.3640 DZE Dental Products Panel Dental Devices Branch
INTENDED USE
The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
1
DEVICE DESCRIPTION
The I Macro 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.
EQUIVALENCE TO MARKETED DEVICE
OCO Biomedical, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the I Macro 6.0mm Implants are substantially equivalent in indications and design principles to the following legally marketed predicate devices:
OCO Biomedical, I Macro Implant System, K110337 OCO Biomedical, TSI & ERI, K090174 "O" Company, Inc., Immediate Stabilizing Implant (ISI), K033392 "O" Company, Inc., OCO Dental Implant (5.0 mm Diameter), K023336 Implant Direct, LLC, Spectra Dental Implant System, K061319 Southern Implants, Inc., Endosseous Dental Implant System, K071161 Megagen Implant Company, LTD, Rescue External Implant System, K081302 Astra Tech AB, Astra Tech Implant System, K101732 Bicon, Inc., 6.0 x 5.7mm Dental Implant, K010185 Bicon, LLC, Bicon Implants with a 2.5mm Internal Connection, K092035 Bicon, LLC, The Bicon 5.0 x 5.0mm and 6.0 x 5.0mm Dental Implant, K073368 Bicon, Inc., The 5.0 x 6.0mm Dental Implant, K062044 Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mm Dental Implant, K050712 Bicon, Inc., The 5.0.x 6.0mm Dental Implant, K042637
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, pull-out testing, and static and dynamic compression-bending testing according to ISO 14801.
The subject device and the predicate devices have the same intended use and have the same technological characteristics. They encompass the same range of physical dimensions, including diameter and length of the implants. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above..
Overall, I Macro 6 x 6 has the following similarities to the predicate devices:
- . has the same intended use,
- uses the same operating principle,
- . incorporates the same basic design,
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
April 5, 2013
OCO Biomedical, Incorporated C/O Ms. Linda K. Schulz PaxMed International, Limited Liability Company 11234 El Camino Real. Suite 200 SAN DIEGO CA 92130
Re: K122198
Trade/Device Name: I Macro 6.0mm x 6.0mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 15, 2013 Received: March 18, 2013
Dear Ms. Schulz:
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. Ilisting 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
3
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 devicerelated 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/CDRH0ffices/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.
Image /page/3/Figure/7 description: The image contains the text "Kwame O. Ulmer - for". The text "FDA" is also present, but it is stylized and difficult to read. The text is arranged in a way that suggests it might be a name or title followed by an affiliation or purpose.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
I Macro 6.0mm X 6.0mm
510(k) Summary
Indications for Use
K122198 510(k) Number:
I Macro 6.0mm x 6.0mm Device Name:
Indications for Use:
The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mary S. Runner -S
Susan Runner, DOSMA 2013.04:03
08:58:13-04'00'
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number: