(102 days)
Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.
The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.
The provided text describes the 510(k) summary for the Intra-Lock® 15° Angled Abutment, a dental device, and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.
The document focuses on:
- Device Identification: Name, common name, classification, and predicate devices.
- Intended Use/Indications: To support prosthetic devices with Intra-Lock® dental implants in partially or fully edentulous patients.
- Technological Characteristics: Narrow prosthetic interface (SQ Platform), magenta anodization.
- Mechanical Testing: Static and dynamic fatigue testing in accordance with ISO 14801:2007.
- Substantial Equivalence: Claim that the device is substantially equivalent to predicate devices based on design, materials, intended use, and operational principles, raising no new safety or effectiveness issues.
There is no mention of acceptance criteria related to algorithms, performance metrics like accuracy, sensitivity, specificity, or any studies involving AI/ML models, human readers, or ground truth establishment for such models.
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AUG - 8 2011
Image /page/0/Picture/2 description: The image shows the logo for INTRA-LOCK International. The logo is in black and white, with the words "INTRA-LOCK" in large, bold letters. Below that, the word "INTERNATIONAL" is written in smaller letters. To the left of the words is a square shape with a U-shaped design inside.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter's Name: | Intra-Lock International6560 West Rogers CircleBoca Raton, FL 33487 |
|---|---|
| Phone: | (561)447-8282 |
| Facsimile: | (561)447-8283 |
| Contact Person: | Diana Taylor |
| Date Prepared: | August 4, 2011 |
| Name of Device: | Intra-Lock® 15° Angled Abutment |
| Common Name: | 15° Angled Abutment |
| Classification Name: | Endosseous Dental Implant Abutment 21 CFR 872.3630 |
| Predicate Devices: | K103194, Intra-Lock® Dental Implant System withBlossom |
| Intended Use/Indications: | Intra-Lock® 15° Angled Abutments are intended for usewith Intra-Lock® dental implants to support a prostheticdevice in partially or fully edentulous patients. Theabutments may be used in single and/or multiple toothapplication in the mandible or maxilla. |
Technological Characteristics: The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.
Mechanical Testing: The subject Intra-Lock® 15°Angled Abutment had static and dynamic fatigue testing performed in accordance with ISO 14801:2007 and submitted in this 510(k).
Substantial Equivalence: The subject Intra-Lock® 15°Angled Abutment has the same basic design, and technological characteristics, identical materials, intended use / indications, principles of operation, instructions for use and packaging as the predicate devices in K103194. The minor differences between the subject Intra-Lock® 15°angled abutment and it's predicate(s) raise no new issues of safety or effectiveness. Therefore, the subject Intra-Lock® 15°angled abutment is substantially equivalent to the predicate abutments.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which includes an abstract representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intra-Lock International, Incorporated C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 6560 West Rogers Circle Boca Raton, Florida 33487
AUG - 8 2011
Re: K111199
Trade/Device Name: Intra-Lock® 15° Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2011 Received: July 29, 2011
Dear Ms. Blackwell:
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 ffor 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.
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Page 2 - Ms. Blackwell
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ugm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 CDRFF'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.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number: K111199
Device Name: Intra-Lock® 15° Angled Abutment
Indications for Use:
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Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.
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) |
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.)