(85 days)
None
No
The summary describes a mechanical dental device and does not mention any AI/ML terms or functionalities.
No
The device is described as an "accessory to endosseous dental implants to support a prosthetic device," indicating its role in supporting another medical device rather than directly treating a condition or disease itself. Its function is to support a "provisional bridge for an immediate load restoration" during healing, not to provide therapy.
No
The device is an accessory to dental implants, intended to support a prosthetic device for a limited period during healing. Its function is structural support, not diagnosis.
No
The device description explicitly states that the QuickBridge provisional components consist of physical hardware: a titanium alloy cylinder and a PEEK Cap.
Based on the provided information, the QuickBridge System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- QuickBridge System Function: The QuickBridge System is a dental device used as an accessory to dental implants to support a prosthetic device in a patient's mouth. It is a physical component used in a surgical/restorative procedure, not a test performed on a biological sample.
The description clearly outlines its use in a clinical setting for supporting dental prostheses, which falls under the category of medical devices, specifically dental devices, rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.
Product codes
NHA
Device Description
The QuickBridge provisional components consist of a non-hexed titanium alloy cylinder and a PEEK Cap. The titanium cylinder threads onto Biomet 3i Conical Abutments that have a 4.8 mm margin diameter. The QuickBridge Cap is made of PEEK and snaps over the QuickBridge Cylinder to allow it to be picked up in a provisional bridge for an immediate load restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
K07155
BOYET 31
AUG 3 0 2007
Summary of Safety and 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, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Diana Taylor
Manager, Regulatory Affairs
Biomet 3i, Inc.
4555 Riverside
Palm Beach Gardens, FL 33410
Tel. 561-776-6857
Fax. 561-776-6852 |
| Date Prepared | June 5, 2007 |
| Device Name | QuickBridge™ Cylinder and Cap |
| Classification Name | Endosseous dental implant abutment |
| Device Classification | Class II
Dental Devices Panel
21 CFR § 872.3630 |
| Legally Marketed Predicate Devices | Certain Provide Temporary Cylinder, K061177, 5/16/06 |
| Device Description | The QuickBridge provisional components consist of a non-
hexed titanium alloy cylinder and a PEEK Cap. The
titanium cylinder threads onto Biomet 3i Conical
Abutments that have a 4.8 mm margin diameter. The
QuickBridge Cap is made of PEEK and snaps over the
QuickBridge Cylinder to allow it to be picked up in a
provisional bridge for an immediate load restoration. |
1
.
| Indications for Use | The QuickBridge System is intended to be mated with
BIOMET 3i conical abutments for use as an accessory to
endosseous dental implants to support a prosthetic device in
a partially or fully edentulous patient. The QuickBridge
System is intended for use to support multiple unit
prostheses in the mandible or maxilla for up to 180 days
during endosseous and gingival healing. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The design modifications for the proposed QuickBridge
Cylinder and Cap 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 QuickBridge Cylinder
and Cap remain substantially equivalent to the predicate
Provide Temporary Cylinder with the Provide Abutment,
and the modifications have not changed the intended use,
altered the fundamental scientific technology or the safety
and effectiveness of the device. |
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana Taylor Manager, Regulatory Affairs Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
AUG 3 0 2007
Re: K071551
Trade/Device Name: QuickBridge Cylinder and Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 5, 2007 Received: June 6, 2007
Dear Ms. Taylor:
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. Taylor
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 (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,
Supa y. Michie Omd
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
Biomet 3i, Inc. Special 510(k) Premarket Notification - QuickBridge™
Indications for Use
510(k) Number (if known): K071551
Device Name: QuickBridge Cylinder and Cap
Indications for Use:
The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K071531 |
|---|---|
| ---------------- | --------- |