(115 days)
Not Found
No
The description details a CAD/CAM process for designing and milling dental bars based on scans, which is a standard digital manufacturing workflow and does not inherently involve AI or ML.
No.
The device is described as an accessory to a dental implant, intended to support a prosthetic device for multiple tooth prostheses. Its function is structural support rather than directly treating a disease or condition for therapeutic effect.
No
This device is described as an accessory to a dental implant, intended to support a prosthetic device. Its description focuses on its manufacturing process (milling from scans) and its function in supporting prostheses, rather than on diagnosing medical conditions.
No
The device description explicitly states that the device is a physical bar milled from titanium alloy or CP titanium, which is a hardware component. While CAD/CAM software is used in the design process, the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support a prosthetic device in a patient, which is a direct clinical application within the body (in vivo).
- Device Description: The device is a physical bar milled from titanium alloy or CP titanium, designed to be implanted or attached to implants in the mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used outside the body (in vitro) to analyze samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device is clearly intended for use within the patient's mouth.
N/A
Intended Use / Indications for Use
The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
Product codes
NHA
Device Description
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient’s impression and then is machined using a CADCAM software system. The bars are milled from titanium alloy or CP titanium.
CAM StructSURE® Precision Milled Bars:
CSHxx CAM StructSURE Hader Bar: 2-10 implants
CSPxx CAM StructSURE Primary Bar: 2-10 implants
CSDxx CAM StructSURE Dolder Bar: 2-10 implants
CSCMxx CAM StructSURE Copy Milled Bar: 4-10 implants
CSIYxx CAM StructSURE Hybrid Bar: 4-10 implants
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical and/or digital scanner
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.)
0
Image /page/0/Figure/2 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a bold, sans-serif font. The letters are blocky and geometric, with a modern and clean design.
JUL 2 1 2008
Summary of Safety & Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 1038806 |
| Contact: | Tamara J. West
International Regulatory Affairs Manager
BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-776-6923
Fax. 561-514 6316
Email twest@3implant.com |
| Date Prepared: | March 27, 2008 |
| Trade/Proprietary Name: | CAM StructSURE® Precision Milled Bars |
| Common/Usual Name: | Overdenture Bar |
| Classification Name: | Endosseous dental implant abutment
21 CFR § 872.3630 |
| Device Classification: | Class II
Dental Devices Panel |
| Legally Marketed Predicate
Devices: | K034035 3i Patient Specific Overdenture Bars |
.
1
1000 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
| Device Description: | All CAM StructSURE® Precision Milled Bars (Dolder,
Primary, Hader, Hybrid and Copy Milled) are designed
to match an individual patient. The bars are designed
from a three-dimensional optical and/or digital scanner
system that scans the casting of a patient's impression
and then is machined using a CADCAM software
system. The bars are milled from titanium alloy or CP
titanium.
CAM StructSURE® Precision Milled Bars:
CSHxx CAM StructSURE Hader Bar:
2-10 implants CSPxx CAM StructSURE Primary Bar:
2-10 implants CSDxx CAM StructSURE Dolder Bar:
2-10 implants CSCMxx CAM StructSURE Copy Milled Bar:
4-10 implants CSIYxx CAM StructSURE Hybrid Bar:
4-10 implants |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The CAM StructSURE® Precision Milled Bars are
intended for use as an accessory to an endosseous dental
implant to support a prosthetic device in a partially or
edentulous patient. It is intended for use to support
multiple tooth prostheses in the mandible or maxilla.
The prostheses can be screw retained. |
| Conclusion: | The proposed design modifications for the CAM
StructSURE® Precision Milled Bars were completed
under Quality System Design Controls in accordance
with 21 CFR 820.30.
Appropriate verification and validation activities were
performed to provide assurance that CAM
StructSURE® Precision Milled Bars remain
substantially equivalent to the predicate and the
modifications have not changed the intended use,
altered the fundamental scientific technology or the
safety and effectiveness of the device. |
:
: : : : :
.
:
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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 consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2008
Ms. Tamara West International Regulatory Affairs Manager BIOMET, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K080864
Trade/Device Name: CAM StructSURE® Precision Milled Bars Regulation Number: 872.3636 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 6, 2008 Received: May 19, 2008
Dear Ms. West:
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. West
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Susan Rimmer
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
4
Image /page/4/Figure/1 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a stylized font. The words "BIOMET" and "3i" are clearly visible in the logo. The logo appears to be for a medical or dental company.
Indications for Use
510(k) Number (if known): K089 864
Device Name: CAM StructSURE® Precision Milled Bars
Indications for Use:
The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susel Rumm
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080864