(248 days)
Not Found
No
The description focuses on the physical characteristics, materials, and mechanical testing of dental implants. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes.
The device is a dental implant intended to restore a patient's chewing function, which is a therapeutic purpose.
No
The device is a dental implant intended for surgical placement to restore chewing function, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy, such as implants and cover screws, indicating it is a hardware device, not software-only.
Based on the provided information, the OsteoCentric Dental Implants are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- OsteoCentric Dental Implants Function: The intended use and device description clearly state that these implants are surgically placed in the jawbone to provide a base for prosthetic teeth, restoring chewing function. They are a physical implant, not a device that analyzes biological samples.
The information provided focuses on the mechanical properties, biocompatibility, and surgical placement of the implant, which are characteristic of a medical device intended for implantation, not an IVD.
N/A
Intended Use / Indications for Use
The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.
Product codes
DZE
Device Description
The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below:
- Root Form Implants:
- Ø 3.5/ 8, 10, 12, and 14 mm o
- Ø 4.0/ 8, 10, 12, and 14 mm O
- Ø 4.5/ 8, 10, 12, and 14 mm O
- Ø 5.0/ 8, 10, 12, and 14 mm O
- Ø 5.5/ 8, 10, 12, and 14 mm O
- Wide Form Implants:
- Ø 4.1/ 8, 10, 12, and 14 mm o
- Ø 4.5/ 8, 10, 12, and 14 mm o
- Ø 5.5/ 8, 10, and 12 mm O
- 6.5/ 8 and 10 mm
Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472).
The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics. Information was shared by Implant Logistics based on a contractual license agreement which was leveraged to demonstrate implant abutment compatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or completely edentulous upper or lower jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following performance data was submitted to demonstrate substantial equivalence:
- Fatigue testing per ISO 14801
- Non-clinical worst-case MRI review was performed to evaluate the devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
The following data was leveraged from the predicate device K173701, this information was shared based on a contractual license agreement with Implant Logistics Inc:
- Biocompatibility
- Sterilization
- Shelf-life
- Packaging Validation
- Modified Surface Testing
- Endotoxin Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
OsteoCentric Technologies Todd Evans Senior Director Quality and Regulatory Affairs 75 W 300 N Suite 150 Logan, Utah 84321
Re: K230242
Trade/Device Name: OsteoCentric Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 5, 2023 Received: September 6, 2023
Dear Todd Evans:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230242
Device Name
OsteoCentric Dental Implants
Indications for Use (Describe)
The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
OsteoCentric Technologies 75 West 300 N, Suite 150 Logan, UT 84321 Phone: 1-800-969-0639
Contact Person: Todd Evans, Senior Director of Quality and Regulatory Affairs Date Prepared: October 5th, 2023
II. Device
| Device Proprietary Name: | OsteoCentric Dental Implants |
|---|---|
| Common or Usual Name: | Dental Implants |
| Classification Name: | Endosseous dental implant |
| Regulation Number: | 21 CFR 872.3640 |
| Product Code: | DZE |
| Device Classification | Class II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- Implant Logistics Implant-One™ System, K173701, Implant Logistics, Inc. ●
IV. Device Description
The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below:
- Root Form Implants: ●
- Ø 3.5/ 8, 10, 12, and 14 mm o
- Ø 4.0/ 8, 10, 12, and 14 mm O
- Ø 4.5/ 8, 10, 12, and 14 mm O
- Ø 5.0/ 8, 10, 12, and 14 mm O
- Ø 5.5/ 8, 10, 12, and 14 mm O
- Wide Form Implants:
- Ø 4.1/ 8, 10, 12, and 14 mm o
- Ø 4.5/ 8, 10, 12, and 14 mm o
- Ø 5.5/ 8, 10, and 12 mm O
5
0 0 6.5/ 8 and 10 mm
Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472).
The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics. Information was shared by Implant Logistics based on a contractual license agreement which was leveraged to demonstrate implant abutment compatibility.
V. Indications for Use
The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OsteoCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.
VI. Comparison of Technological Characteristics
| | OsteoCentric Dental Implant
System | Implant Logistics Implant-One™
System
(K173701) | Analysis |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Endosseous Implants | | | |
| Design | Root-form
Wide form | Root-form
Wide-form | Identical |
| Material | Titanium and/or titanium alloy | Titanium and/or titanium alloy | Identical |
| Method of
Stabilization | Threaded fixation | Threaded fixation | Identical |
| Implant
Offerings | Root Form Implants:
Ø 3.5/ 8, 10, 12, and 14 mm
Ø 4.0/ 8, 10, 12, and 14 mm
Ø 4.5/ 8, 10, 12, and 14 mm
Ø 5.0/ 8, 10, 12, and 14 mm
Ø 5.5/ 8, 10, 12, and 14 mm
Wide Form Implants:
Ø 4.1/ 8, 10, 12, and 14 mm
Ø 4.5/ 8, 10, 12, and 14 mm
Ø 5.5/ 8, 10, and 12 mm
Ø 6.5/ 8 and 10 mm | Root Form Implants:
Ø 3.5/ 8, 10, 12, and 14 mm
Ø 4.0/ 8, 10, 12, and 14 mm
Ø 4.5/ 8, 10, 12, and 14 mm
Ø 5.0/ 8, 10, 12, and 14 mm
Ø 5.5/ 8, 10, 12, and 14 mm
Wide Form Implants:
Ø 4.1/ 8, 10, 12, and 14 mm
Ø 4.5/ 8, 10, 12, and 14 mm
Ø 5.5/ 8, 10, and 12 mm
Ø 6.5/ 8 and 10 mm | Identical |
The table below provides a comparison between the subject and predicate devices.
6
| | OsteoCentric Dental Implant
System | Implant Logistics Implant-One™
System
(K173701) | Analysis |
|----------------------|---------------------------------------|-------------------------------------------------------|-----------|
| Implant
Carrier | No
Small gripping feature added | Yes | Different |
| Surface
Treatment | Resorbable media blasted | Resorbable media blasted | Identical |
| Sterile | Yes | Yes | Identical |
| Cover Screws | | | |
| Material | Titanium and/or titanium alloy | Titanium and/or titanium alloy | Identical |
| Sterile | Yes | Yes | Identical |
As noted in the table above, the subject and predicate devices are identical with respect to design, materials of construction, method of stabilization, implant size offerings, surface treatment, and sterility status. A gripping feature was introduced to the implant to eliminate the need for a carrier; however, as demonstrated by fatigue testing, the introduction of this feature does not impact substantial equivalence.
VII. Performance Data
The following performance data was submitted to demonstrate substantial equivalence:
- Fatigue testing per ISO 14801 ●
Non-clinical worst-case MRI review was performed to evaluate the devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque. "
The following data was leveraged from the predicate device K173701, this information was shared based on a contractual license agreement with Implant Logistics Inc:
- Biocompatibility ●
- Sterilization ●
- Shelf-life
- Packaging Validation ●
- Modified Surface Testing ●
- Endotoxin Testing ●
7
VIII. Conclusion
The information provided above supports that the OsteoCentric Dental Implants are substantially equivalent to the predicate device.