(110 days)
No
The document describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes.
The device is used for oral rehabilitation of edentulous and partially dentate patients, which is a therapeutic purpose.
No
This device is a dental implant system used for oral rehabilitation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical implant made of titanium, packaged sterile, and intended for surgical implantation. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for oral rehabilitation through dental implant applications. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed in the jawbone. This is a medical device, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a dental implant system, which falls under the category of medical devices used for surgical and restorative purposes.
N/A
Intended Use / Indications for Use
The Stern AC Dental Implant System 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 Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.
The Stern AC Dental Implant System is only intended for use with straight abutments.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.
The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:
Straumann Rn Synocta - K073628
Straumann SynOcta Meso Abutments - K033243
Straumann RC Temporary Abutments - K093027
Straumann RC Cementable abutments - K072071
Stern IC Solid Abutments - K111798
They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.
Thread Major Diameter (mm)
3.3mm
4.0 mm
5.0mm
Overall Implant Length (mm)
10.0, 11.5, 13.0mm
8.5, 10.0, 11.5, 13.0, 15.0mm
8.5, 10.0mm
The Stern AC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments.
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 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. SEM photographs are enclosed showing all residue of blasting material was removed from the surface.
Sterilization validation was conducted on the proposed 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.
Sterngold Acid Etch Dental Implant System (K023580), Stern IC Dental Implant System (K111798)
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.
Straumann Rn Synocta - K073628, Straumann SynOcta Meso Abutments - K033243, Straumann RC Temporary Abutments - K093027, Straumann RC Cementable abutments - K072071, Stern IC Solid Abutments - K111798
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7,2015
Sterngold Dental LLC Ms. Maria Rao Director of Regulatory Affairs 23 Frank Mossberg Drive Attleboro, Massachusetts 02703
Re: K142667
Trade/Device Name: Stern AC Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 11, 2014 Received: December 12, 2014
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
Page 2 - Ms. Rao
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Susan Runno DDS, MA
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
2
510(k) Number (if known): __K142667
Device Name: Stern AC Dental Implant System
Indications for Use:
The Stern AC Dental Implant System 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 Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments.
The Stern AC Dental Implant System is only intended for use with straight abutments.
(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: Stern AC Dental Implant System
Sponsor: Sterngold Dental, LLC 23 Frank Mossberg Drive Attleboro, MA 02703
Contact: Maria Rao, QA/RA Director Ph: 508-226-5660 ext 1206
Date: January 5, 2015
Device Generic Name: Endosseous Dental Implant system
Classification: Endosseous Dental Implant, 872.3640, Class II
Product Code: DZE
Predicate Devices:
The Stern AC Dental 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, including the Sterngold Acid Etch Dental Implant System (K023580), and Stern IC Dental Implant System (K111798).
Product Description:
The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 titanium. The implant is acid etched except for the neck, which is machined to a smooth finish. Stern AC Implants are manufactured with a flared neck, used for one-stage, transgingival implantation. The neck and body include an internal taper and octagon. The implants are manufactured with three body diameters, 3.3 mm, 4.0 mm, and 5.0 mm, all with the same prosthetic head.
The proposed implants are prosthetically compatible with the Straumann ITI implant system and the Stern IC Dental Implant System previously approved for market:
Straumann Rn Synocta - K073628 Straumann SynOcta Meso Abutments - K033243 Straumann RC Temporary Abutments - K093027 Straumann RC Cementable abutments - K072071 Stern IC Solid Abutments - K111798
They are packaged sterile in a double blister, which contains implant with an implant mount screw secured in a titanium tube. The Mount Body is screwed into the using the mount screw, which keeps it in place. This configuration is known as "Direct Delivery", which allows the surgeon to transport the implant from the package to the prepared implant site and save chairside time. The proposed Stern AC Dental Implant will be available in a range of lengths and diameters.
4
Thread Major Diameter (mm) 3.3mm 4.0 mm
Overall Implant Length (mm)
10.0, 11.5, 13.0mm 8.5, 10.0, 11.5, 13.0, 15.0mm 8.5, 10.0mm
The Stern AC Dental Implant System is not intended for correction of implant fixtures placed at an angle. It is only intended for use with straight abutments.
Indications for Use:
5.0mm
The Stern AC Dental Implant System 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 Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable abutments and Stern IC Solid Abutments. The Stern AC Dental Implant System is only intended for use with straight abutments.
Substantial Equivalence:
The proposed Stern AC 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.
Technological Characteristics:
The Stern AC dental Implant provides the same or similar functions as well as design and technological characteristics as the predicate devices listed. In addition the surface is identical to the cleared Sterngold Acid Etched Implant.
The materials, technology and facilities used to produce the Stern AC Dental Implants are the same as other Sterngold Dental Implants previously approved and cleared by FDA.
The proposed Stern AC dental implant has the same materials, same manufacturing process and surface treatment as previously cleared Sterngold Acid Etch dental implant and Stern IC Dental Implant. This surface is widely used in the industry primarily by the Straumann Company under the name "SLA".
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| Property | Stern AC Dental
Implant System
(Proposed Device) | Sterngold Acid Etch Dental
Implant System
(K023580) | Sterngold Stern IC Dental
Implant System
(K111798) |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implant Design | Self-tapping, threaded, Root-form implant | Self-tapping, threaded, Root-form implant | Self-tapping, threaded, Root-form implant |
| Implant Sizes
(diameter*) x (length) | 3.3x10.0mm | 3.75x8.5mm | 3.3x1.8x8.0mm |
| | 3.3x11.5mm
3.3x13mm
4.0x8.5mm
4.0x10.0mm
4.0x11.5mm
4.0x13.0mm
4.0x15.0mm
5.0x8.5mm
5.0x10.0mm | 3.75x10.0mm
3.75x11.5mm
3.75x12.0mm
3.75x13.0mm
3.75x15mm
4.0x8.5mm
4.0x10.0mm
4.0x13.0mm | 3.3x1.8x10.0mm
3.3x1.8x12.0mm
3.3x1.8x14.0mm
4.1x1.8x8.0mm
4.1x1.8x10.0mm
4.1x1.8x12.0mm
4.1x1.8x14.0mm |
| Abutment
Compatibility | Internal Connection | External Connection | Internal Connection |
| Implant Stage | Stage 1 and Stage 2 | Stage 1 and Stage 2 | Stage 1 and Stage 2 |
| External Screw
Threads | Yes | Yes | Yes |
| Placement Accessories | Implant drills, twist drills, countersinks, bone
taps, insertion tool | Implant drills, twist drills, countersinks, bone
taps, insertion tool | Implant drills, twist drills, countersinks, bone taps,
insertion tool |
| Supplied Sterile | Yes | Yes | Yes |
| Intended Use | 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 Stern AC Dental Implant System
is intended for delayed loading. It is also
indicated for immediate loading with good
primary stability and appropriate occlusal
loading. | Implantation into any area of the partially and/or
fully edentulous maxilla and mandible for the
support of a removable or fixed dental
prosthesis. Intended for single tooth or multiple
unit prosthesis. | Long term surgical implantation in the bone of the
patient's upper or lower arch to provide immediate load
or delayed load of prosthetic systems, such as artificial
teeth, in order to restore the patient's chewing function.
Also indicated for for immediate loading with good
primary stability and appropriate occlusal loading |
| Implant Material | CP Titanium titanium grade 4 | CP Titanium titanium grade 4 | CP Titanium titanium grade 4 |
| Implant Surface | Blasted with aluminum oxide particles and acid
etched | Blasted with aluminum oxide particles and acid
etched | Blasted with aluminum oxide particles and acid etched |
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. SEM photographs are enclosed showing all residue of blasting material was removed from the surface.
Sterilization validation was conducted on the proposed devices.
Conclusion:
Based on our analysis, the device is substantially equivalent in intended use, material, design and performance to its predicate devices, Sterngold Acid Etch Dental Implant System (K023580) and Stern IC Dental Implant System (K111798).