(174 days)
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Not Found
No
The description focuses on a mechanical dental handpiece for dispensing paste, with no mention of AI/ML terms or functionalities.
No.
The device is described as a dispenser for a hemostatic/gingival retracting agent, not the agent itself or a device that directly treats a condition.
No
The device is described as a dental handpiece used to dispense a hemostatic/gingival retracting agent. It aids in a treatment, not in diagnosing a condition.
No
The device description explicitly states it is a "dental handpiece" and is connected to a "micro-motor," indicating it is a physical hardware device.
Based on the provided information, the Expasyl Power Applicator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Expasyl Power Applicator is a dental handpiece used to dispense a paste directly into the mouth for gingival retraction and hemostasis. It is a tool used in a dental procedure, not for analyzing a biological sample.
The description clearly states its purpose is to dispense a dental material for a clinical procedure, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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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.
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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
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties, along with the date JAN 3 2006. To the right of the logo is the code K 051933. The logo is a stylized "sds" with a swoosh above it. The text "SYBRON DENTAL SPECIALTIES" is below the logo.
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: July 2005
Device Name:
- Trade Name Expasyl Power Applicator .
- Common Name Dental Handpiece .
- Classification Name Dental Handpiece and Accessories, per 21 CFR § 872.4200 .
- Devices for Which Substantial Equivalence is Claimed:
- . Electro Medical Systems, EMS Air-Flow handy 2
Device Description:
The Expasyl Power Applicator is a dental handpiece intended to dispense Expasyl, a temporary hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator. The Expasyl Power Applicator is connected to any micro-motor (air or electric) that has a coupling socket and a maximum speed of 40,000 rpm. When the capsule of Expasyl is empty, the plunger on the Expassyl Power Applicator rotates and the applicator makes a repetitive clicking noise which signals the micro-motor must be stopped. The capsule holder of the Expasyl Power Applicator is autoclaveable.
Intended Use of the Device:
The intended use of the Expasyl Power Applicator is to dispense Expasyl, a temporary hemostatic/gingival retracting agent.
Substantial Equivalence:
The Expasyl Power Applicator is substantially equivalent to other legally marketed devices in the United States. The Expasyl Power Applicator functions in a manner similar to and is intended for a similar use as the product Air-Flow handy 2 cleared for marketing for Electro Medical Systems.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 3
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re: K051933
Trade/Device Name: Expasyl Power Applicator Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 14, 2005 Received: December 15, 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 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 - Ms. Boswell
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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
3
Indications for Use
510(k) Number (if known):
Device Name: Expasyl Power Applicator
Indications For Use:
The Expasyl Power Applicator is a dental handpiece intended to be used to dispense Expasyl, a hemostatic/gingival retracting agent. The paste is dispensed through a tip attached to the cartridge of Expasyl through the use of the Expasyl Power Applicator.
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)
Susan Runner
| (Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number | K051933 |
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