(89 days)
The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.
The Enhance Dental Implant System (Enhance System) is a system of threaded root-form dental implants and abutments.
This document, K061335, describes the 510(k) premarket notification for the Coastal Biocare Enhance Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for a new device's efficacy or safety.
Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not applicable or cannot be extracted from this document. The document primarily functions as a regulatory submission outlining the device's characteristics and its equivalence to already marketed devices.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable. This document does not specify performance-based acceptance criteria for the Enhance Dental Implant System itself, nor does it present a study that reports device performance against such criteria. The 510(k) process for this type of device relies on demonstrating substantial equivalence to predicate devices. The "criteria" are met by showing similar intended use, design, materials, and functional characteristics to devices already cleared by the FDA.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. No specific "test set" in the context of clinical performance evaluation is mentioned. The submission is a regulatory filing, not a clinical study report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. There is no mention of a test set or ground truth established by experts in this document.
4. Adjudication Method for the Test Set:
- Not Applicable. There is no mention of a test set or adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document does not describe an MRMC comparative effectiveness study. The focus is on device characteristics and regulatory equivalence.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical dental implant system, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- Not Applicable. No ground truth, in the context of clinical or performance data, is mentioned or used in this submission. The "truth" for this submission is regulatory equivalence to predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. There is no mention of a "training set" in the context of a study for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no mention of a "training set" or its ground truth.
Summary of Information Present in the Document:
While the document doesn't fit the requested structure for a performance study, it does contain important information relevant to the device:
- Device Name: Enhance Dental Implant System
- Intended Use: "The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing."
- Device Description: Threaded root-form dental implants with a finely grooved tapered collar, made of commercially pure titanium, with internal hex. Includes straight abutments, cover screws, and a retainer screw.
- Materials: Implants made of CP titanium Grade 4 (ASTM F 67), abutments of Ti-6Al-4V ELI alloy (ASTM F136).
- Sterilization: Co6 gamma irradiation at 25 kGy (2.5 Mrad) for implants; other components provided non-sterile.
- Equivalence to Marketed Device: The submission states that the Enhance Dental Implant System is substantially equivalent in indications and design principles to predicate devices. This means that its intended use, design, materials, and functional characteristics are substantially the same as devices already cleared by the FDA.
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Enhance Dental Implant System
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510(k) Summary
Coastal Biocare Enhance Dental Implant System
AUG - 9 2006
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Coastal Biocare2737 South Croddy Way Unit DSanta Ana, CA 92704Telephone (714) 751-0121FAX (714) 751-0115 |
|---|---|
| Official Contact: | Candy Pravitz |
| Representative/Consultant: | Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236 |
| DEVICE NAME | |
| Classification Name: | Implant, Endosseous, Root-Form |
Abutment, Implant, Dental, Endosseous Trade/Proprietary Name: Enhance Dental Implant System Common Name: Dental implant, Dental Implant Abutments
DEVICE CLASSIFICATION
FDA has classified "Implant, Endosseous, Root-Form" as a Class II device (21 CFR 872.3640), with product code DZE. "Abutment, Implant, Dental, Endosseous" has a product code of NHA and is classified as Class II (872.3630). Endosseous dental implants and abutments are reviewed by the Dental Products Panel.
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INTENDED USE
The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.
DEVICE DESCRIPTION
The Enhance Dental Implant System (Enhance System) is a system of threaded root-form dental implants and abutments.
Design
Implants of the Enhance System are threaded endosseous dental implants with a finely grooved tapered collar. The implants are made of commercially pure titanium and are offered in a variety of lengths and diameters. Implants are configured with an internal hex to aid in surgical insertion and to prevent rotation of restorations. The Enhance System includes straight abutments of several types, cover (healing) screws and a retainer screw used to secure hex-configured abutments in place. Enhance System implants are individually packaged in a carrier vial that is sealed within a radiation-sterilizable Tyvek pouch. The other Enhance System components are provided non-sterile and are packaged in Tyvek pouches.
Material
Enhance System implants are made of CP titanium Grade 4, conforming to ASTM F 67 with abutments of Ti-6Al-4V ELI alloy conforming to ASTM F136.
Sterilization
Sterilization will be accomplished by means of Co6 gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad).
EQUIVALENCE TO MARKETED DEVICE
Coastal Biocare demonstrated that, for the purposes of FDA's regulation of medical devices, the Enhance Dental Implant System is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
The intended use, design, materials and functional characteristics of the Enhance Dental Implant System and the predicate devices are substantially the same. All are indicated for use in the bone of the maxillary and/or mandibular arch and are made of CP titanium and Ti-6Al-4V ELI titanium alloy, well-proven materials for implantable devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures standing side-by-side. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2006
Coastal Biocare C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K061335
Trade/Device Name: Enhance Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 4, 2006 Received: August 7, 2006
Dear Mr. Larson:
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 mershate comments, 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 the Federal F UGA, Drag, Lrag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided 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 (1 wirt), it may be back of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Mr. Larson
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 and thoung (2 - - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as lectronic 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premiuree nown on one 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Simite Y. Michael Davis
Sir. Li, Ph.D.
Chiu Lin, Ph.D. 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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K061335 – Additional Information
Enhance Dental Implant System
INDICATIONS FOR USE
510(k) Number: K061335
Device Name:
Enhance Dental Implant System
Indications for Use:
The Enhance Dental Implant System is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. It may be placed immediately in an extraction site or may be placed after bone healing.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunne
. . . . . . . . . . . Off) in of Anesthesiology, General Hospital, Colon Control, Dental Devices
. - () Rumber:
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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.