PREMIER ETCH
Device Facts
| Record ID | K141839 |
|---|---|
| Device Name | PREMIER ETCH |
| Applicant | Premier Dental Products Co. |
| Product Code | KLE · Dental |
| Decision Date | Nov 17, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Intended Use
Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Device Story
Premier Etch is a 37% phosphoric acid gel used by dental professionals in a clinical setting. It is applied to dentin or enamel surfaces to prepare the tooth structure for bonding agents during restorative procedures. The acidic gel demineralizes the tooth surface to improve adhesion of restorative materials. It is a manual, non-electronic device.
Clinical Evidence
Bench testing only.
Technological Characteristics
37% phosphoric acid gel; chemical etching agent; manual application; non-electronic; no software.
Indications for Use
Indicated for use by dental professionals to etch dentin or enamel prior to tooth restoration procedures.
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
- K022492 — PULPDENT SEMI-GEL ETCH · Pulpdent Corporation · Oct 11, 2002
- K120213 — ETCH-RITE SUPREME · Pulpdent Corporation · Mar 30, 2012
- K152110 — e-1 etchants · E Dental Products · Nov 20, 2015
- K131248 — ETCH GEL · Dmg America, LLC · Jul 11, 2013
- K200462 — EtchPro Etching Gel · Belport Company, Inc., Gingi-Pak · Sep 2, 2020
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17,2014
Premier Dental Company Products Mr. Vincent D'Alessandro Regulatory Manager 1710 Romano Drive Plymouth Meeting, PA 19462
Re: K141839
Trade/Device Name: Premier Etch Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 7, 2014 Received: November 7, 2014
Dear Mr. D'Alessandro:
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.
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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/1 description: The image shows the word "premier" in red, bold letters. The word is inside of a red oval with rounded corners. The background is white.
1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. 888-773-6872 / 610-239-6000 www.premusa.com
## Indications for Use
510(k) Number (if known): _K141839
Device Name: Premier Etch
Indications for Use: Premier Etch is a prescription- only, 37% phosphoric acid etchant in a gel form that is used by the dental professional for etching dentin or enamel prior to tooth restoration.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
