(16 days)
Not Found
Not Found
No
The device description and intended use describe a paste for gingival retraction and hemostasis, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device facilitates temporary retraction and hemostasis during dental procedures, which are temporary actions to aid the procedure rather than treating a disease or condition itself.
No
This device is a paste used for temporary retraction and hemostasis of the gingival margin during dental procedures. Its function is to prepare the gingival tissue, not to diagnose a condition.
No
The device description clearly states it is a paste containing aluminum chloride and is applied using a manual dispensing gun, indicating it is a physical product with hardware components, not software only.
Based on the provided information, this device 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.
- Expa-syl's Function: Expa-syl is a paste applied directly to the gingival margin (part of the gum) during dental procedures. Its purpose is to physically retract the gum and control bleeding. It does not analyze a sample taken from the body to diagnose or monitor a condition.
Therefore, Expa-syl falls under the category of a dental device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Expa-syl is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Product codes (comma separated list FDA assigned to the subject device)
MVL
Device Description
Expa-syl is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. The paste is extruded through the tip attached to the cartridge and applied into the sulcus through the use of the manual dispensing gun. The paste is left in place between 1 to 2 minutes, depending upon the tonicity of the marginal gingiva, and then removed by an air and water spray with simultaneous aspiration. A dry, retracted sulcus is obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival margin
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
FEB 11 2005
sds
SYBRON DENTAL SPECIALTIES
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: January 2005
Device Name:
- . Trade Name - Expa-syl
- Common Name Gingival Retraction/Hemostatic Paste .
- Classification Name Unclassified .
Devices for Which Substantial Equivalence is Claimed:
- . Coltene/Whaledent, Stav-put Impregnated
- Ultradent Products, Inc., Ultrapak E .
Device Description:
Expa-syl is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. The paste is extruded through the tip attached to the cartridge and applied into the sulcus through the use of the manual dispensing gun. The paste is left in place between 1 to 2 minutes, depending upon the tonicity of the marginal gingiva, and then removed by an air and water spray with simultaneous aspiration. A dry, retracted sulcus is obtained.
Intended Use of the Device:
The intended use of Expa-syl is for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Substantial Equivalence:
Expa-syl is substantially equivalent to other legally marketed devices in the United States. Expa-syl functions in a manner similar to and is intended for the same use as the products Stay-put Impregnated and Ultrapak E cleared for marketing for Coltene/Whaledent and Ultradent Products, Inc., respectively.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2005
Produits Dentaires Pierre Rolland C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K050180
Trade/Device Name: Expa-SylTM Regulation Number: N/A Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: January 24, 2005 Received: January 26, 2005
Dear Ms. Boswell:
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 nrior 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 n your de need it onestional 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. Colleen Boswell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i nease be advised that I 27 r ination that your device complies with other requirements of the Act or that I Drived a deceminations administered by other Federal agencies. You must comply with all 1 caelar statutes and 16 gendarding, but not limited to: registration and listing (21 CFR Part 807); an the Ave 3 requirements) ; good manufacturing practice requirements as set forth in the quality idoceming (2) 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 premainst noutheation " a 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 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 yours,
Q
Shiu-S. Lien, Ph.D.
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
િલ્લાના નિર્માન કામાં આવેલા ગુજરાત રાજ્યના ભારત દેશના પાકની ખેત 510(k) Number (if known):
Device Name: Expa-syl
Indications For Use:
Expa-syl is a paste containing aluminum chloride which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Prescription Use V (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)
Susan Kunze
Civision Sian-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K050180