(94 days)
No
The document describes a physical dental implant and its specifications. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is an implantable screw intended for long-term applications in bone, facilitating the stability and fixation of dental restorations, which directly addresses a medical condition (edentulous cases) and aims to restore normal function.
No
This device is described as a self-tapping titanium threaded screw intended for long-term applications in the bone, used for dental implants. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical implant made of titanium alloy, which is a hardware component.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. They are used for fixing crown and bridge installations. This is a surgical implant placed directly into the body, not a device used to test samples outside the body.
The text focuses on the physical characteristics of the implant, its placement in bone, and its use in dental restoration. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications. These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention. The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.
Product codes
DZE, NHA
Device Description
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V - ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V - ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation. The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary. The MOR Dental Implant will be available in a range of lengths and diameters: 2.1mm diameter with 10mm, 13mm, 15mm lengths; and 2.4mm diameter with 10mm, 13mm, 15mm lengths. Dimensional requirements for the finished abutment: Angulation of final abutment: No angles, Minimum and Maximum Gingival Height: 1.0 - 3.0mm, Minimum abutment post height may be fabricated to: 4.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's upper or lower arch (bone)
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)
Performance Testing: Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use. Proposed devices have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices. As a result, the MOR Implant System is substantial equivalent to its predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IMTEC Sendax - MDI and MDI Plus (K031106)
Reference Device(s)
Sterngold - ERA Implant (K021045), Intra-Lock International - Mini Drive-Lock Dental Implant System (K070601), Sterngold Acid Etch Dental Implant System (K023580)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
Sterngold Dental, LLC Ms. Maria Rao Director of QA & Regulatory Affairs 23 Frank Mossberg Dr. Attleboro, Massachusetts 02703
Re: K153173
Trade/Device Name: MOR Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 30, 2015 Received: November 3, 2015
Dear Ms. Rao:
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. 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
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 (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K153173 510(k) Number (if known):
Device Name: MOR Implant System
Indications for Use:
MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications.
These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use (21 CFR 807 Subpart D)
3
510(k) Summary
Trade Name: MOR Implant System
Sponsor: Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703
Contact: Maria Rao. OA/RA Director Ph: 508-226-5660 ext 1206
Date: February 3, 2016
Device Generic Name: Endosseous Dental Implant System
Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II
Classification Name: Endosseous Dental Implant
Product Code: DZE (21CFR 872.3640) NHA
Predicate Devices:
The MOR Implant System is substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process.
- Primary Predicate IMTEC Sendax - MDI and MDI Plus (K031106)
- Reference Predicates ● Sterngold - ERA Implant (K021045) Intra-Lock International - Mini Drive-Lock Dental Implant System (K070601)
- Sterngold Acid Etch Dental Implant System (K023580)
Product Description:
The MOR is a self-tapping, small diameter, screw implant, manufactured from titanium alloy (6% Al, 4% V - ASTM F136). The portion of the implant that is submerged in the bone is grit blasted and acid etched. The implants are manufactured with two body diameters, 2.1 mm and 2.4 mm. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. The MOR implant body is designed with an O-ball denture connection and a separate straight titanium alloy (6% AI, 4% V - ASTM F136) abutment which may be cemented over the O-ball for crown or bridge fixation.
The MOR Implant System is not intended for correction of implants placed at an angle. It is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.
4
The MOR Dental Implant will be available in a range of lengths and diameters.
| Thread Major Diameter (mm) | Overall Implant Length (mm) |
|---|---|
| 2.1mm | 10mm, 13mm, 15mm |
| 2.4mm | 10mm, 13mm, 15mm |
Dimensional requirements for the finished abutment:
Angulation of final abutment: No angles Minimum and Maximum Gingival Height: 1.0 - 3.0mm Minimum abutment post height may be fabricated to: 4.0mm
Indications for Use:
MOR Implants are self-tapping titanium threaded screws intended for long-term applications in the bone of the patient's upper or lower arch. The MOR implants may also be used for interradicular transitional applications.
These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulous cases, and employing minimally invasive surgical intervention.
The MOR Implant System is only intended for use with straight abutments. The MOR implant body is intended to be placed such that no angle correction is necessary.
Substantial Equivalence:
The MOR Dental implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process. The intended use, basic design, fundamental operating principles are the same as the predicate devices.
Indications for use are similar to predicates devices. Changes do not affect the intended use of the product. Overall operating principles and mechanism are the same.
Technological Characteristics:
The MOR dental Implant provides the same or similar functions as well as design and technological characteristics as the predicate devices. In addition the surface is identical to the cleared Sterngold Acid Etched Implant (K023580).
The abutment is the same or similar to the predicate devices - intended use, design and function. The materials, technology and processes used to produce the MOR dental implants and abutments are the same as other Sterngold Dental devices previously cleared by the FDA. Any differences between the proposed devices and its predicates do not make the device not substantially equivalent. See chart below for list of similarities and differences.
Performance Testing:
Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class 11 Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use.
5
Proposed devices have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the proposed new devices. As a result, the MOR Implant System is substantial equivalent to its predicates.
Conclusion:
Based on our analysis, technological characteristics and performance testing, the MOR Implant System is substantially equivalent in intended use, material, design and performance to its predicates.
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Sterngold Dental, LLC
Abbreviated 510(k) Premarket Notification
February 3, 2016
MOR Implant System
| | MOR Dental Implant System
Sterngold Dental | MDI and MDI Plus Implants
(K031106)
IMTEC Sendax | ERA Implant
(K021045)
Sterngold Dental | Mini-Drive Lock Dental
Implant (K070601)
Intra-Lock Int. | Implant System
(K023580)
Sterngold Dental |
|---------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Property | Proposed Device | Primary Predicate | Reference Predicate | Reference Predicate | Reference Predicate |
| Intended Use | See Indications for Use
Statement above | Indicated for long-term intra-
bony applications. Additionally,
the MDI may also be used for
inter-radicular transitional
applications. These devices will
permit immediate splinting
stability and long-term fixation
of new or existing crown and
bridge installations, for full
partial endentulism, and
employing minimally invasive
surgical intervention. | Intended for surgical placement
in edentulous anterior regions of
maxillary and/or mandibulary
arch to provide temporary
support and permit
immediate stability and ongoing
fixation of new or existing crown
and bridge applications for full
or partial dentures with minimal
invasive surgical intervention | Intended for use as a self-
tapping titanium screw for
transitional or intra-bony long-
term applications. Mini Drive-
Lock TM Dental Implants are
indicated for long-term
maxillary and mandibular
tissue-supported denture
stabilization. Multiple implants
should be used and may be
restored after a period of time
or placed in immediate
function. | Intended for implantation into
any area of the partially or fully
edentulous maxilla and
mandible for the support of
removable or fixed dental
prosthesis. For single tooth or
multiple units |
| Implant Design | Threaded, Root-form implant | Threaded, Root-form implant | Threaded, Root-form implant | Threaded, Root-form implant | Threaded, Root-form implant |
| Implant Shape | Cylinder | Cylinder | Cylinder | Cylinder | Cylinder |
| Implant Body Diameter | 2.1mm, 2.4mm | 2.1mm, 2.4mm, 2.9mm | 2.2mm | 2.0mm, 2.5mm | 3.3mm, 4.0mm, 5.0mm |
| Implant Length | 10mm, 13mm, 15mm | 10mm, 13mm, 15mm, 18mm | 10mm, 13mm, 15mm | 10mm, 11.5mm, 13mm, 15mm
and 18mm | 8.5mm, 10mm, 11.5mm, 13mm,
15mm |
| Surface | Blasted with aluminum oxide
particles and acid etched | Roughened - HA blasted | Blasted with aluminum oxide
particles and acid etched | Roughened - HA blasted | Blasted with aluminum oxide
particles and acid etched |
| Abutment Connection Style | External Connection | N/A | Internal Connection | N/A | External Connection |
| Prosthetic Platform | Square | Denture O-Ball | Hex | Denture O-Ball | Hex |
| Implant Material | Wrought Titanium 6AL-4V
ELI | Wrought Titanium 6AL-4V
ELI | Wrought Titanium 6AL-4V
ELI | CP Titanium grade 4 | Wrought Titanium 6AL-4V
ELI |
| Manufacturing Process | Machining | Machining | Machining | Machining | Machining |
| Implant Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| Abutment Material | Wrought Titanium 6AL-4V
ELI | N/A | Wrought Titanium 6AL-4V
ELI | N/A | CP Titanium grade 4 |
| Manufacturing Process | Machining | Machining | Machining | Machining | Machining |
| Abutment Sterilization | Moist Heat (Steam) | N/A | Moist Heat (Steam) | N/A | Moist Heat (Steam) |
| Abutment Angulation | No Angles | No Angles | No Angles | No Angles | No Angles |