SEITY 37% PHOSPHORIC ACID ETCHANT GEL
Device Facts
| Record ID | K112597 |
|---|---|
| Device Name | SEITY 37% PHOSPHORIC ACID ETCHANT GEL |
| Applicant | Mycone Dental Supply Co., Inc. |
| Product Code | KLE · Dental |
| Decision Date | Dec 7, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Intended Use
A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations.
Device Story
Seity 37% Phosphoric Acid Etchant Gel is a dental material used by dentists to prepare tooth surfaces for restorative procedures. The gel is applied to enamel, dentin, or glass ionomer cements to create a micro-retentive surface, which improves the adhesion of dental restorative materials. It is a thixotropic formulation, meaning it maintains its shape during application but flows under pressure. The device is used in a clinical dental setting by licensed practitioners. By etching the tooth structure, the gel facilitates the bonding process, ultimately helping to secure restorations and improve clinical outcomes for the patient.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Thixotropic gel containing 37% phosphoric acid. Formulated for dental etching of enamel, dentin, and glass ionomer cements. Class II device, product code KLE.
Indications for Use
Indicated for dental patients requiring etching of enamel, dentin, or glass ionomer cements to facilitate bonding of dental restorations.
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
Related Devices
- K150696 — Jade 37% Phosphoric Acid Etchant Gel · Dharma Research, Inc. · Jun 23, 2015
- K152110 — e-1 etchants · E Dental Products · Nov 20, 2015
- K131248 — ETCH GEL · Dmg America, LLC · Jul 11, 2013
- K172953 — Acid Etchant · American Orthodontics · Feb 6, 2018
- K120213 — ETCH-RITE SUPREME · Pulpdent Corporation · Mar 30, 2012
Submission Summary (Full Text)
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mycone Dental Supply Company, Incorporated Mr. William Evans QA Regulatory Associate Keystone Industries and Deepak Products 616 Hollywood Avenue Cherry Hill, New Jersey 08002
Re: K112597
Trade/Device Name: Seity 37% Phosphoric Acid Etchant Gel Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 30, 2011 Received: December 1, 2011
Dear Mr. Evans:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
DEC - 7 2011
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## Page 2 - Mr. Evans
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Lunares
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
## Enclosure
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## Indications for Use
K112597
510(k) Number (if known):
Device Name: Seity 37% Phosphoric Acid Etchant Gel
Indications For Use:
A thixotropic 37% phosphoric acid dental etchant gel for etching enamel, dentin, and glass ionomer cements to produce the necessary micro-retentive surface for successful bonding of restorations. .. ..
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rayer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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