(85 days)
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Not Found
No
The device description focuses on the physical characteristics, materials, and compatibility of the dental implant system. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is a dental implant system intended for implantation into the jawbone to support dental prostheses, which is a therapeutic purpose.
No
Explanation: The device description clearly states it is an "endosseous dental implant system" used "for the support of a removable or fixed dental prosthesis," indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical components made of titanium, such as implants, cover screws, and an insertion tool. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for implantation into the maxilla and mandible to support dental prostheses. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
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 Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:
· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For single tooth or multiple unit prosthesis
Product codes (comma separated list FDA assigned to the subject device)
DZE (21CFR872.3640)
Device Description
The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded. root-form endosseous implants that will be available is a variety of sizes to suit individual user/patient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration.
The proposed implants are compatible with standard, regular platform (4.1mm), external-hex (antirotational) abutments such as the currently marketed Sterngold-Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants.
The Sterngold Acid Etch Implants will be available in the following sizes:
Diameter (mm) / Overall Length (mm)
3.75 / 8.5, 10, 11.5, 13, 15, 18
4.00 / 8.5, 10, 13, 15
5.00 / 8.5, 10
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
maxilla 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
Not Found
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)
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:
- Overview of Information Necessary for Premarket Notification Submissions for Endosseous . Implants (FDA Guidance)
- . Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)
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.
Not Found
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
October 21, 2002 Acid Etch Dental Implant System
510(k) Summary
| Trade Name: | Sterngold Acid Etch Dental Implant System | JAN 1 7 2003 |
|---|---|---|
| Sponsor: | Sterngold | |
| 23 Frank Mossberg Drive | ||
| Attleboro, MA 02703 | ||
| Device Generic Name: | Dental endosseous implant system | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class III | ||
| Product Code: | DZE (21CFR872.3640) |
Predicate Devices:
The Sterngold Acid Etch 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, including the Implant Innovations Osseotite Dental Implant System and the Nobel Biocare MKIII Dental Implant System.
Product Description:
The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded. root-form endosseous implants that will be available is a variety of sizes to suit individual user/patient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration.
The proposed implants are compatible with standard, regular platform (4.1mm), external-hex (antirotational) abutments such as the currently marketed Sterngold-Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants.
The Sterngold Acid Etch Implants will be available in the following sizes:
| Diameter (mm) | Overall Length (mm) |
|---|---|
| 3.75 | 8.5, 10, 11.5, 13, 15, 18 |
| 4.00 | 8.5, 10, 13, 15 |
| 5.00 | 8.5, 10 |
Indications for Use:
The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:
· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For single tooth or multiple unit prosthesis
Safety and Performance:
This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket
1
Image /page/1/Picture/0 description: The image contains the text 'K0a 3580' in a handwritten style. The characters are written in black ink on a white background. The text appears to be a code or identifier, possibly a serial number or a reference code.
Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:
- Overview of Information Necessary for Premarket Notification Submissions for Endosseous . Implants (FDA Guidance)
- . Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)
Conclusion:
Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold Acid Etch Dental Implant System has been shown to be safe and effective for the product's intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
JAN 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sterngold C/O Ms. Pamela Papineau Delphi Medical Consulting, Incorporated 5 Whitcomb Avenue Aver, Massachusetts 01432
Re: K023580
Trade/Device Name: Sterngold Acid Etch Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant System Regulatory Class: III Product Code: DZE Dated: October 21, 2002 Received: October 24, 2002
Dear Ms. Papineau:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Ms. Papineau
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Page
510(k) Number (if known): K023580
Sterngold Acid Etch Dental Implant System Device Name:
Indications for Use:
The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:
· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
- · For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For single tooth or multiple unit prosthesis
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻠﮯ Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K022380
000008