(131 days)
3i's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.
The Conical Angled Abutments are designed to interface with 3i's internal and external connected implants. They will be available in 17° and 25° angles. The seating surface will be 4.1mm and 5.0mm diameters and the transmucosal tissue heights will be 2.0mm and 4.0mm. They will be manufactured out of Titanium Alloy.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for a dental device (Conical Angled Abutments), and it primarily focuses on describing the device, its classification, predicate devices, and an FDA letter confirming substantial equivalence.
It explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug, and Cosmetic Act." This indicates that the approval for this device was based on substantial equivalence to a legally marketed predicate device, rather than meeting specific performance criteria demonstrated through a clinical study.
Therefore, I cannot provide the requested table or details about studies, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the given text.
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Summary of Safety and Effectiveness
MAR 2 0 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Tamara NelsonRegulatory Affairs SupervisorImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-514 6316Email: tnelson@3implant.com |
| Date Prepared | 03 November 2006 |
| Device Name | Conical Angled Abutments |
| Classification Name | Endosseous Dental Implant Abutment |
| DeviceClassification | Class IIDental Devices Panel21 CFR § 872.3630 |
| PredicateDevices | Conical Abutment -> K933462 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The Conical Angled Abutments are designed to interfacewith 3i's internal and external connected implants. Theywill be available in 17° and 25° angles. The seating surfacewill be 4.1mm and 5.0mm diameters and the transmucosaltissue heights will be 2.0mm and 4.0mm. They will bemanufactured out of Titanium Alloy. |
| Indications for Use | 3i's Conical Angled Abutments are indicated for use insingle and multiple unit cases and as custom copings wheretissue depth, as measured from the crest of the tissue to the |
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shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations.
The Conical Angled Abutments contain features and functions similar to the currently available Conical Abutments.
The Conical Angled Abutments in this submission are substantially equivalent to the legally marketed Conical Abutments.
Technological Characteristics
Conclusion
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tamara Nelson Regulatory Affairs Supervisor Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
MAR 2 0 2007
Re: K063403
Trade/Device Name: Conical Angled Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 9, 2007 Received: March 12, 2007
Dear Ms. Nelson:
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.
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Page 2 – Ms. Nelson
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 (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.
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 vour 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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
Enclosure
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Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Conical Angled Abutments
Indications for Use:
31's Conical Angled Abutments are indicated for use in single and multiple unit cases and as custom copings where tissue depth, as measured from the crest of the tissue to the shelf of the implant; angulation of the implant in relation to other implants or adjacent dentition; and, interarch distance measured form the shelf of the implant to the opposing dentition, provide for improved emergence profiles and contours for esthetic restorations. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Kusno
KC62403
Prescription Use: (Per 21 CFR 801.109) OR
Over the Counter Use:
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)