(86 days)
The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.
The 3i Patient-Specific Overdenture Bars are designed to match individual patients.
This 510(k) premarket notification for Implant Innovations, Inc.'s 3i Patient-Specific Overdenture Bars focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI/software-as-a-medical-device (SaMD).
Therefore, the provided document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies, as these types of studies are typically associated with validating the performance of diagnostic or therapeutic devices that rely on novel algorithms or measurements.
The document primarily focuses on:
- Device Description: 3i Patient-Specific Overdenture Bars are designed to match individual patients and are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in partially or edentulous patients.
- Intended Use: To support multiple tooth prostheses in the mandible or maxilla, with the prostheses being screw-retained to the abutment.
- Predicate Devices: Various overdenture bars (Hader, Dolder, Primary) and specifically K974150 Nobel Biocare, Inc. Procera® Preparable Abutment System.
- Safety and Effectiveness Summary: Mentions historical problems with overdenture bars (fractures of screws, loose screws, improper mating leading to inflammation) but does not provide details on how the 3i device addresses these with specific performance data.
- Substantial Equivalence: The FDA's letter states the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as the predicate devices, or if there are differences, they do not raise different questions of safety and effectiveness.
In summary, the provided document is a 510(k) clearance letter for a medical device (patient-specific overdenture bars) that is demonstrating substantial equivalence to existing predicate devices. It does not contain the detailed performance study information, including acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies, that would be associated with the validation of an AI/SaMD diagnostic or therapeutic product.
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Implant Innovations, Inc. 510(k) Premarket Notification - 3i Patient-Specific Dental Abutments
MAR 2 4 2004
Image /page/0/Picture/3 description: The image shows a logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" with the "i" resembling a dental implant. Below the "3i" are the words "IMPLANT INNOVATIONS, INC." and "A BIOMET COMPANY" in a smaller font.
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Summary of Safety & Effectiveness
| COMPANY: | Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
|---|---|
| CONTACT: | Jim Banic Regulatory Affairs Specialist Telephone: 561-776-6932 Fax: 561-514-6316 E-mail: jdailey@3implant.com |
| DATE PREPARED: | December 26, 2003 |
| NAME OF THE DEVICE: | 3i Patient-Specific Overdenture Bar |
| CLASSIFICATION: | DZE Class III |
| COMMON NAME: | Overdenture Bar |
| PREDICATE DEVICES: | The 3i Patient-Specific Overdenture Bars are substantially equivalent to overdenture bars, (commonly referred to as Hader, Dolder, and Primary) currently on the market in overall design and intended use. Overdenture bars have been in existence for more than thirty years and have been traditionally fabricated in individual dental laboratories. |
| Predicate device includes: | |
| K974150 Nobel Biocare, Inc. Procera® Preparable Abutment System |
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Implant Innovations, Inc. 510(k) Premarket Notification - 3i Patient-Specific Dental Abutments
| DEVICE DESCRIPTION: | The 3i Patient-Specific Overdenture Bars aredesigned to match individual patients. |
|---|---|
| INDICATIONS FOR USE: | The 3i Patient-Specific Overdenture Bars areintended for use as an accessory to an endosseousdental implant to support a prosthetic device in apartially or edentulous patient. It is intended for useto support multiple tooth prostheses, in themandible or maxilla. The prostheses are screwretained to the abutment. |
| SUMMARY OF SAFETY ANDEFFECTIVENESS: | Safety and effectiveness problems that have beenencountered with overdenture bars usedwith endosseous implants may include occasionalfractures of the screw; screws becoming loose; orimproper mating resulting in inflammation. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest movement and progress.
Public Health Service
MAR 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K034035
Trade/Device Name: 3i Patient-Specific Overdenture Bars Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: December 26, 2003 Received: December 29, 2003
Dear Mr. Banic:
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 -- Mr. Banic
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 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) 594-5613. 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 vours,
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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Indications for Use
S10(k) Number (if known): K034035
Device Name: 3i Patient-Specific Overdenture Bars
Indications for Use:
The 3i Patient-Specific Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in an edentulous or partially edentulous patient. It is intended for use to support multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be screwed retained.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suso Rtmps
ion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K034035
Page 1 of 1
§ 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.)