(21 days)
Not Found
No
The summary describes a chemical gel for topical application and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device is indicated for topical application to remove the smear-layer on exposed root surfaces during periodontal surgery, which is a preparation step for surgery rather than a therapeutic action itself.
No
Explanation: The device is an EDTA gel used for topical application during periodontal surgery to remove the smear-layer, not to diagnose a condition.
No
The device description clearly states it is an EDTA gel for topical application, indicating it is a physical substance, not software.
Based on the provided information, the Straumann© PrefGel™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application onto exposed root surfaces during periodontal surgery to remove the smear-layer. This is a direct application to a patient's tissue in vivo (within the living body).
- Device Description: It's described as an EDTA gel for topical application. This aligns with a therapeutic or surgical aid, not a diagnostic test performed on samples in vitro (outside the living body).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue samples), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Straumann© PrefGel™'s function is to prepare a surface during surgery, which is a therapeutic/surgical intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Straumann© PrefGel™ is indicated for topical application onto exposed root surfaces during periodontal surgery in order to selectively remove the smear-layer PrefGel has been shown to mod remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.
Product codes
KJJ
Device Description
PrefGel is an EDTA gel used for topical application prior to periodontal surgery to remove the smear-layer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
exposed root surfaces
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
The proposed device is substantially equivalent to the currently marketed PrefGel in terms of performance characteristics tested and biocompatibility.
Key Metrics
Not Found
Predicate Device(s)
PrefGel (K940737)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Section 9 510(K) SUMMARY
jan 1 2 2007
| SPONSOR: | Straumann
60 Minuteman Road
Andover, MA 01810 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Lisa M. Quaglia
Regulatory Affairs and Clinical Research Director
Tel: (978) 747-2575 |
| DATE OF SUBMISSION: | December 21, 2006 |
| DEVICE: | Straumann® PrefGel |
| Trade Name: | PrefGel™ |
| Common Name: | Root Surface Conditioning Gel |
| Classification: | Dental
Classified Under 21 CFR Part 872.3690.
Classified as a Class II Device. |
| PREDICATE DEVICE: | PrefGel (K940737) |
| DEVICE DESCRIPTION: | PrefGel is an EDTA gel used for topical application
prior to periodontal surgery to remove the smear-layer. |
| INTENDED USE: | PrefGel is intended for topical application onto exposed
root surfaces during periodontal surgery in order to
remove the smear-layer. PrefGel has been shown to
effectively remove the smear-layer. PrefGel has also
been shown to produce a fibrilliar collagenous
meshwork on the exposed and conditioned surface by
selective removal of mineral. In addition, PrefGel does
not induce any detectable necrosis in the surrounding
periodontal tissues. |
| COMPARISON OF
CHARACTERISTICS: | The proposed device is substantially equivalent to
currently marketed device. They share the same
intended use, same design characteristics, and the same
method of application. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to the
currently marketed PrefGel in terms of performance
characteristics tested and biocompatibility. |
·
:
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
JAN 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Quaglia Regulatory Affairs and Clinical Research Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K063812
Trade/Device Name: PrefGel™ Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 21, 2006 Received: December 22, 2006
Dear Ms. Quaglia:
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.
2
Page 2 - Ms. Lisa M. Quaglia
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" (21 CFR 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. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Sincerely yours,
Susan Puon
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known) K063812
Page 1 of 1
Device Name Straumann PrefGel™™
Indications for Use The Straumann© PrefGel™ is indicated for topical application onto
exposed root surfaces during periodontal surgery in order to selectively
remove the smear-layer PrefGel has been shown to mod
remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.
Prescription Use X (Per 21 CFR 801.109)
ーーーーー
OR
Over the Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Ruan
General Hos
vices
K063812
Special 510(k) Premarket Notification for Straumann® PrefGel Proprietary and Confidential Information of Straumann®