(13 days)
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No
The summary describes a dental implant system, which is a physical device, and contains no mention of software, algorithms, or AI/ML terms.
No.
The device is an implant system used for dental rehabilitation, which is a structural component and not a device that provides therapy.
No
This device is described as an implant system for oral rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly states "Sterngold Impla Med Hex Screw Implant, TPS and HA Coated," which describes a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dental implant system for oral rehabilitation. This is a surgical/implantable device used directly in the body, not a device used to examine specimens (like blood, urine, or tissue) outside the body to provide diagnostic information.
- Device Description: The description is of a physical implant, not a diagnostic test or reagent.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.
Therefore, the Sterngold ImplaMed Implant System is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentuous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.
Product codes
DZE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxillae and mandible
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
MAY 1 1 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Hickey ·Director, QA/RA Sterngold ImplaMed® 23 Frank Mossberg Drive P.O. Box 2967 02703-0967 Attleboro, Massachusetts
Re : K981516 Sterngold ImplaMed® Hex Screw Implants TPS Trade Name: and HA Coated Sterngold Requlatory Class: ırı Product Code: DZE April 21, 1998 Dated: Received: April 28, 1998
Dear Ms. Hickey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
1
Page 2 - Ms. Hickey
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acbertised in your bir my puivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
MAY 01" "98 " 02:37PM 508 226 5473
Carlos Concession Comers FDA - ODF: DDIGD
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Eage
510(k) Number (if known): K98-1516
Device Name: Sterngold Impla Med Hex Screw Implant, TPS and HA Coated.
Indications For Use:
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentuous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTITIVUE ON ANOTHER PAGE IF NEEDED)
Con :urrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Cortal, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801. 109) OR
Over-The-Countcx Use
(Optional Format 1-2-96)
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