(108 days)
No
The document describes physical dental implants and their components, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is for oral rehabilitation to support dental restorations, not for treating a disease or condition.
No
This device is a dental implant system intended for oral rehabilitation, which is a treatment rather than a diagnostic function.
No
The device description clearly details physical components made of Titanium 6AL-4V ELI, such as endosseous dental implants, abutments, and cover screws. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for "oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations." This is a surgical and restorative procedure performed directly on a patient's body.
- Device Description: The device description details physical implants made of Titanium, designed to be surgically placed in bone. It discusses features like threads, surfaces for osseointegration, and prosthetic components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a medical implant.
N/A
Intended Use / Indications for Use
The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
PUR 3.2mm Implant System
The PUR 3.2mm Implant System consists of 3.2mm threaded endosseous dental implants, as well as prosthetic components The prosthetic components include a Straight Narrow Platform Slim Abutment with a 1.5mm and 3.0mm cuffs and a 0.050' Hex Prosthetic Screw. The purpose of the Slim Abutments is to provide surgical and prosthetic options for smaller spaces. They attach directly to the implant with the aid of the prosthetic screw and provide the transitional link between the head of the implant and the restorative components. These abutments are straight and not intended for angulation. The PUR Straight Slim Abutments are similar to FDA cleared PUR Straight Abutments Narrow and Regular Platforms 1.5mm and 3.0mm cuffs (K151928). The difference is the body of the proposed Straight Narrow Platform Slim Abutment is more tapered. The abutments and prosthetic screw are made of Titanium 6AL-4V ELI. The ancillary component is a 3.2mm cover screw, which is flush with the top surface of the implant to prevent tissue and bone from growing inside the implant. It is screwed onto the immediately after implant placement. It is made of Titanium 6AL-4V ELI. The PUR 3.2mm implant is an endosseous dental implant made of Titanium 6AL-4V ELI with a treated roughened surface (blasted and etched). The implant body is tapered with double-lead threads and10 start micro threads at the collar. The implant lengths are 8mm, 10mm, 12mm and 14 mm. This implant The PUR 3.2mm implant features the same prosthetic platform as the 3.5mm and 4.3mm implants already cleared by FDA (K151928). The purpose of the 3.2mm PUR implant is to provide surgical and prosthetic options for smaller spaces. The PUR 3.2mm Implants will be provided "Sterile" using Gamma sterilization.
MOR 3.0mm Implant System
The MOR 3.0mm Implant System consists of 3.0mm endosseous dental implants. The MOR 3.0mm implant is a one-piece endosseous dental implant, manufactured of Titanium 6AL-4V ELI. The portion of the implant that is submerged in the bone is a treated roughened surface (blasted and etched) to facilitate osseointegration. The MOR 3.0mm implant is similar in design to the MOR 2.4mm implant previously cleared by FDA. The implant lengths are10mm, 13mm, 15mm, and 18mm. The implant has two prosthetic head design options - 0-ball identical to Sterngold MOR 2.4mm Implant (K153173), and a Tapered Abutment similar to the IMTEC MDI MII One Piece Implant 2.9mm (K081653). This implant has the same design threads as the MOR 2.4mm Implant. The MOR Implants will be provided "Sterile" using Gamma sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla and mandible
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 test data was used to support substantial equivalency. Performance testing of the MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm was implemented the FDA guidance Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments.
Biocompatibility: A risk assessment was performed to identify biological hazards and evaluate estimated risks of known hazards. The evaluation of the biological safety of the proposed devices and their materials consisted of intended use, device characteristics, biological hazard identification, and exposure assessment. A biological evaluation was then performed in accordance with EN ISO 10993-1. The final device was considered during evaluation as well as materials, processes, physical characteristics and properties of finished device, intended use, contact type and duration.
Surface Treatment Analysis: MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are blasted with white aluminum oxide particles followed by acid etching. SEM and EDS analysis was performed on the blasted implant surface of a final device. SEM photographs and surface analysis confirm that residue and contaminants from the blasting material were not present or detectable in any form and implant surface was homogeneous.
Sterilization and Shelf-Life Validation: MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are provided sterile and are sterilized using Cobalt 60 gamma radiation VD max25 method that has been validated to ensure a SAL of 10° per BS EN ISO 11137-1: 2015 and BS EN ISO 11137-2: 2015. The Abutments, temporary Cap, prosthetic screw and drills are provided non-sterile and sterilized prior to use by the end user using moist heat sterilization. Validation was conducted according to ANSI/AAMI/ISO 17665-1: 2006 and 17665-2: 2009. The overkill method was used to develop a cycle (time and temperature) that would provide a Sterility Assurance Level (SAL) of 10°. The devices were tested to a SAL of at least106 using the biological indicator overkill method. The MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are Jabeled sterile with a 5-year shelf life supported by validation performed on Sterngold's own devices. Validation testing using the Accelerated Aging method was conducted and results indicated a successful sterility; dye, burst and aerosol challenge tests showed that the packaging is able to maintain a sterile barrier for up to five (5) years. Shelf life validation was performed according to AAMI/ ANSI /ISO 11607-1: 2006/(R) 2010. LAL testing was conducted as per the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Torque Testing: Testing consisted of a torque test, which simulates the intended use of the proposed devices. Each implant size was tested to determine how they would perform being inserted in different density test blocks by measuring their final insertion torque values. Very dense urethane foam blocks were used to place the implants in so as to attain high torque values to test for breakage. All implants were placed without any breakage. The testing goal was to greatly exceed the torque that would be encountered clinically. It was observed that even at 60Ncm, the proposed implants performed successfully with no evidence of breakage. Torque testing and implant to abutment compatibility demonstrated conformance to design input and indications for use.
Conclusion: The proposed devices have the same technological characteristics, performance specifications and intended use as of its predicates. Performance testing data and intended use supports a determination of substantial equivalence of the proposed devices to the predicate and the reference devices.
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.
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.
Predetermine 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Sterngold Dental, LLC Maria Rao Director of OA & Regulatory Affairs 23 Frank Mossberg Drive Attleboro, Massachusetts 02703
Re: K171728
Trade/Device Name: MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1 x 18mm and 2.4x18mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 25, 2017 Received: August 29, 2017
Dear Maria 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 (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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171728
Device Name
MOR 3.0mm and PUR NP 3.2mm Implant Systems MOR 2.1x18mm and 2.4x18mm
Indications for Use (Describe)
The MOR™ implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. The MOR™ implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summarv
Submitter's Information: 1.
| Name: | Sterngold Dental, LLC |
|---|---|
| Address: | 23 Frank Mossberg Drive |
| Attleboro, MA 02703 | |
| Phone: | 508-226-5660 ext 1206 |
| Contact: | Maria Rao, QA/RA Director |
| Date Prepared: | September 28, 2017 |
| Device Name: | |
| Trade Name: | MOR 3.0mm and PUR 3.2mm Implant Systems |
| MOR 2.1x18mm and 2.4x18mm | |
| Regulation Number: | 21 CFR 872.3640 |
| Product Code: | DZE, NHA |
| Classification Name: | Endosseous dental implant |
| Classification: | Class II |
3. Predicate Devices:
Primary Predicates
Prismatik Inclusive Tapered implant - K153099 IMTEC MDI MII One-Piece Implant 2.9mm - K081653
Reference Predicates
Sterngold PUR Implant System - K151928 Implant Direct Spectra System Dental Implants 2008 - K090234 Sterngold MOR 2.1mm and 2.4mm - K153173
4. Product Description:
PUR 3.2mm Implant System
The PUR 3.2mm Implant System consists of 3.2mm threaded endosseous dental implants, as well as prosthetic components
The prosthetic components include a Straight Narrow Platform Slim Abutment with a 1.5mm and 3.0mm cuffs and a 0.050' Hex Prosthetic Screw. The purpose of the Slim Abutments is to provide surgical and prosthetic options for smaller spaces. They attach directly to the implant with the aid of the prosthetic screw and provide the transitional link between the head of the implant and the restorative components. These abutments are straight and not intended for angulation.
The PUR Straight Slim Abutments are similar to FDA cleared PUR Straight Abutments Narrow and Regular Platforms 1.5mm and 3.0mm cuffs (K151928). The difference is the body of the proposed Straight Narrow Platform Slim Abutment is more tapered. The abutments and prosthetic screw are made of Titanium 6AL-4V ELI. The ancillary component is a 3.2mm cover screw, which is flush with the top surface of the implant to prevent tissue and bone from growing inside
4
the implant. It is screwed onto the immediately after implant placement. It is made of Titanium 6AL-4V ELI.
The PUR 3.2mm implant is an endosseous dental implant made of Titanium 6AL-4V ELI with a treated roughened surface (blasted and etched). The implant body is tapered with double-lead threads and10 start micro threads at the collar. The implant lengths are 8mm, 10mm, 12mm and 14 mm. This implant The PUR 3.2mm implant features the same prosthetic platform as the 3.5mm and 4.3mm implants already cleared by FDA (K151928). The purpose of the 3.2mm PUR implant is to provide surgical and prosthetic options for smaller spaces. The PUR 3.2mm Implants will be provided "Sterile" using Gamma sterilization.
MOR 3.0mm Implant System
The MOR 3.0mm Implant System consists of 3.0mm endosseous dental implants. The MOR 3.0mm implant is a one-piece endosseous dental implant, manufactured of Titanium 6AL-4V ELI. The portion of the implant that is submerged in the bone is a treated roughened surface (blasted and etched) to facilitate osseointegration. The MOR 3.0mm implant is similar in design to the MOR 2.4mm implant previously cleared by FDA. The implant lengths are10mm, 13mm, 15mm, and 18mm. The implant has two prosthetic head design options - 0-ball identical to Sterngold MOR 2.4mm Implant (K153173), and a Tapered Abutment similar to the IMTEC MDI MII One Piece Implant 2.9mm (K081653). This implant has the same design threads as the MOR 2.4mm Implant. The MOR Implants will be provided "Sterile" using Gamma sterilization.
ട്. Indications for Use:
The MOR" implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The MOR" implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
The PUR Implants are intended to be used for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. These implants are intended for delayed loading. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
The PUR implants are only intended for use with straight abutments. The implant body is intended to be placed such no angle correction is necessary.
6. Substantial Equivalence:
The device comparison outlined on Table 2 provides the similarities and substantial equivalency of the proposed devices to its predicates. The comparative data demonstrates that the MOR 3.0mm, PUR 3.2mm Dental Implant Systems, and 2.1x18mm and 2.4 x18mm Implants are substantially equivalent to the predicate devices. They have the same or similar indications for use, design and technological characteristics.
The PUR 3.2mm Dental Implants with lengths of 8, 10, 12 and 14mm are substantially equivalent to predicate devices previously cleared under K090234. The 3.2 x 8mm is similar to the 3.2 x 8mm implant approved under K090234 with same or similar indications for use. Any differences between the proposed devices and the predicate devices do not introduce new concerns in safety and efficacy and does not render the device NSE. Technological characteristics demonstrate the device is as safe and as effective as the predicate devices.
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| Attributes | Proposed Devices
Ø3.0mm MOR Implant | Predicate Device
IMTEC MDI Ø2.9mm
Implant
(K081653) | Reference Predicate
Sterngold
MOR Dental Implant
System (K153173) | Attributes | Proposed Device
Ø3.2mm PUR Implant | Predicate Device
(K153099)
Prismatik Inclusive
Tapered Implant | Reference Predicate
Implant Direct
Spectra System Dental
Implants 2008
(K090234) | Reference Predicate
Sterngold
PUR Dental Implant
System
(K151928) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Picture of
Implant | Image: Proposed Devices Ø3.0mm MOR Implant | Image: Predicate Device IMTEC MDI Ø2.9mm Implant (K081653) | Image: Reference Predicate Sterngold MOR Dental Implant System (K153173) | Picture of
Implant | Image: Proposed Device Ø3.2mm PUR Implant | Image: Predicate Device (K153099) Prismatik Inclusive Tapered Implant | Image: Reference Predicate Implant Direct Spectra System Dental Implants 2008 (K090234) | Image: Reference Predicate Sterngold PUR Dental Implant System (K151928) |
| Implant
Design | Threaded, Root-form implant | Threaded, Root-form implant | Threaded, Root-form implant | Implant
Design | Threaded, Root-form
implant | Threaded, Root-form
implant | Threaded, Root-form
implant | Threaded, Root-form
implant |
| Implant
Connection | Internal Hex | Internal Hex | Internal Hex | Implant
Connection | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| Implant Body
Geometry | Screw Type | Screw Type | Screw Type | Implant Body
Geometry | Screw Type | Screw Type | Screw Type | Screw Type |
| Intended Use | The MOR™ implants are
intended to be used for oral
rehabilitation of edentulous and
partially dentate patients in the
maxilla and mandible to
support single unit, and
multiple unit restorations.
Implant retained restorations
may consist of single crowns or
bridges as well as complete or
partial dentures. These implants
are intended for delayed
loading. Immediate loading is
indicated when there is good
primary stability and an
appropriate occlusal load.
The MOR™ implants are only
intended for use with straight
abutments. The implant body is
intended to be placed such no
angle correction is necessary | Intended to be used for oral
rehabilitation of edentulous and
partially dentate patients in the
maxilla and mandible to support
single unit, and multiple unit
restorations. Implant retained
restorations may consist of
single crowns or bridges as well
as complete or partial dentures.
These implants are intended for
delayed loading. Immediate
loading is indicated when there
is good primary stability and an
appropriate occlusal load.
The PUR implants are only
intended for use with straight
abutments. The implant body is
intended to be placed such no
angle correction is necessary | Intended for long-term
applications in the bone of
the patient's upper or lower
arch. The MOR implants 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
or partial edentulous cases,
and employing minimally
invasive surgical
intervention. | Intended Use | The PUR Implants are
intended to be used for
oral rehabilitation of
edentulous and partially
dentate patients in the
maxilla and mandible to
support single unit, and
multiple unit restorations.
Implant retained
restorations may consist of
single crowns or bridges as
well as complete or partial
dentures. These implants
are intended for delayed
loading. Immediate
loading is indicated when
there is good primary
stability and an
appropriate occlusal load.
The PUR implants are
only intended for use with
straight abutments.
The
implant body is intended
to be placed such no angle
correction is necessary. | Indicated for use in
maxillary and mandibular
partially or fully
edentulous cases, to
support single, multiple-
unit, and overdenture
restorations. The implants
are to be used for
immediate loading only in
the presence of primary
stability and appropriate
occlusal loading. | The Spectra-System Dental
Implant 2008 system is
comprised of dental
implant fixtures and
prosthetic devices that
compose a two-piece
implant system. The Dental
Implants are intended for
use in the mandible and
maxilla, in support of
single unit or multiple unit
cement or screw-receiving
restorations and for the
retention and support of
overdentures. The implants
are intended for immediate
placement and function for
the support of single-tooth
or multiple-tooth
restorations, recognizing
bone stability and
appropriate occusal load
requirements. | It can be used in dental
implant applications, for
oral rehabilitation of
edentulous and partially
dentate patients in the
maxilla and mandible.
Implant retained
restorations may consist of
single crowns or bridges as
well as complete or partial
dentures. The PUR Implant
is intended for delayed
loading. It is also indicated
for immediate loading with
good primary stability and
appropriate occlusal
loading. |
| Implant
Material | Wrought Titanium 6AL-4V
ELI | Wrought Titanium 6AL-4V ELI | Wrought Titanium 6AL-4V
ELI | Implant
Material | Wrought Titanium 6AL-
4V ELI | Wrought Titanium 6AL-
4V ELI | Wrought Titanium 6AL-
4V ELI | Wrought Titanium 6AL-
4V ELI |
| Implant
Surface | Roughened - blasted and acid
etched | Roughened - blasted and acid
etched | Roughened - blasted and acid
etched | Implant
Surface | Roughened - blasted and
acid etched | Roughened - blasted and
acid etched | Roughened - blasted and
acid etched | Roughened - blasted and
acid etched |
| Ø Diameters
(mm) | 3.0mm
2.1mm and 2.4mm | 2.9mm | 2.1mm, 2.4mm | Ø Diameters
(mm) | 3.2mm | 3.2mm | 3.2, 3.7, 4.2, 4.7,5.2, 5.7,
7.0mm | 3.5mm, 4.3mm, 5.0mm,
6.0mm |
| Lengths (mm) | 10mm, 13mm, 15mm, 18mm | 10mm, 13mm, 15mm, 18mm | 10mm, 13mm, 15mm | Lengths (mm) | 8mm, 10mm,12mm,
14mm | 11.5mm, 13mm, 16mm | 8.0mm | 8.0mm, 10mm, 12mm,
14mm |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | | | | | |
Device Comparison – MOR 3.0mm Implant System
6
7
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation | Gamma irradiation |
|---|---|---|---|---|
| Abutment | ||||
| Angulation | No Angulation | 0° - 15° | No Angulation | No Angulation |
| Abutment | ||||
| Material | Wrought Titanium 6AL- | |||
| 4V ELI | Wrought Titanium 6AL- | |||
| 4V ELI | Wrought Titanium 6AL- | |||
| 4V ELI | Wrought Titanium 6AL- | |||
| 4V ELI | ||||
| Construction | Machined | Machined | Machined | Machined |
| Abutment | ||||
| Sterilization | Moist Heat | Moist Heat | Moist Heat | Moist Heat |
PUR NP Slim Abutments and Prosthetic Screw
| Attributes | Proposed Devices
PUR NP Straight Abutment Slim 1.5mm
& 3.0mm and
.050" Hex Prosthetic Screw | Reference Predicate
Sterngold
PUR Straight Abutment 1.5mm and 3.0mm
and
0.48" Prosthetic Screw
(K151928) |
|---------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Design | Image: Proposed Devices | Image: Reference Predicate |
| Material | Wrought Titanium 6AL-4V ELI | Wrought Titanium 6AL-4V ELI |
| Surface | Smooth | Smooth |
| Ø Diameters
(mm) | 1.5mm, 3.0mm | 1.5mm, 3.0mm |
| Hex | .050" | .048" |
| Sterilization | Moist Heat | Moist Heat |
| Single Use | Yes | Yes |
PUR NP Cover Screw
| Attributes | Proposed Devices
PUR NP Cover Screw 3.2mm | Reference Predicate
Sterngold
PUR Cover Screw (K151928) |
|---------------------|-------------------------------------------------|----------------------------------------------------------------|
| Design | Image: Proposed Device PUR NP Cover Screw 3.2mm | Image: Reference Predicate Sterngold PUR Cover Screw (K151928) |
| Material | Wrought Titanium 6AL-4V ELI | Wrought Titanium 6AL-4V ELI |
| Surface | Smooth | Smooth |
| Ø Diameters
(mm) | 3.2mm | 3.5, 4.3, 5.0, 6.0mm |
| Sterilization | Gamma | Gamma |
| Single Use | Yes | Yes |
8
7.0 Summary of Non-Clinical Performance Testing
Non-clinical test data was used to support substantial equivalency.
Performance testing of the MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm was implemented the FDA guidance Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments.
7.1 Biocompatibility
A risk assessment was performed to identify biological hazards and evaluate estimated risks of known hazards. The evaluation of the biological safety of the proposed devices and their materials consisted of intended use, device characteristics, biological hazard identification, and exposure assessment. A biological evaluation was then performed in accordance with EN ISO 10993-1. The final device was considered during evaluation as well as materials, processes, physical characteristics and properties of finished device, intended use, contact type and duration.
The subject device was compared to the new device and the old submission biocompatibility was sufficient to support SE. There were no changes to material composition or manufacturing process.
7.2 Surface Treatment Analysis
MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are blasted with white aluminum oxide particles followed by acid etching. SEM and EDS analysis was performed on the blasted implant surface of a final device.
SEM photographs and surface analysis confirm that residue and contaminants from the blasting material were not present or detectable in any form and implant surface was homogeneous.
7.3 Sterilization and Shelf-Life Validation
MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are provided sterile and are sterilized using Cobalt 60 gamma radiation VD max25 method that has been validated to ensure a SAL of 10° per BS EN ISO 11137-1: 2015 and BS EN ISO 11137-2: 2015. The Abutments, temporary Cap, prosthetic screw and drills are provided non-sterile and sterilized prior to use by the end user using moist heat sterilization. Validation was conducted according to ANSI/AAMI/ISO 17665-1: 2006 and 17665-2: 2009. The overkill method was used to develop a cycle (time and temperature) that would provide a Sterility Assurance Level (SAL) of 10°. The devices were tested to a SAL of at least106 using the biological indicator overkill method.
The MOR 3.0mm, and PUR 3.2mm Implant Systems, MOR 2.1x18mm and MOR 2.4x18mm are Jabeled sterile with a 5-year shelf life supported by validation performed on Sterngold's own devices. Validation testing using the Accelerated Aging method was conducted and results indicated a successful sterility; dye, burst and aerosol challenge tests showed that the packaging is able to maintain a sterile barrier for up to five (5) years. Shelf life validation was performed according to AAMI/ ANSI /ISO 11607-1: 2006/(R) 2010.
LAL testing was conducted as per the FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
9
7.4 Torque Testing
Testing consisted of a torque test, which simulates the intended use of the proposed devices. Each implant size was tested to determine how they would perform being inserted in different density test blocks by measuring their final insertion torque values. Very dense urethane foam blocks were used to place the implants in so as to attain high torque values to test for breakage.
All implants were placed without any breakage. The testing goal was to greatly exceed the torque that would be encountered clinically. It was observed that even at 60Ncm, the proposed implants performed successfully with no evidence of breakage. Torque testing and implant to abutment compatibility demonstrated conformance to design input and indications for use.
8.0 Conclusion:
The proposed devices have the same technological characteristics, performance specifications and intended use as of its predicates. Performance testing data and intended use supports a determination of substantial equivalence of the proposed devices to the predicate and the reference devices.