(70 days)
Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the device "Pharmaethyl Local Pulp and Vitality Testing Agent" and its Indications for Use statement. However, it does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.
This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device, and does not include the technical study report that would contain the requested information.
Therefore, I cannot provide the requested table and study details based on the input text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 92001
Specialites Septodont C/O Mr. Peter S. Reichertz Official Correspondent Arent fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue NW Washington, District of Columbia 20036-5339
Re: K012427
Trade/Device Name: Pharmaethyl Local Pulp and Vitality Testing Agent Regulation Number: 872.1720 Regulation Name: Pulp Tester Regulatory Class: II Product Code: EAT Dated: July 30, 2001 Received: July 31, 2001
Dear Mr. Reichertz:
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.
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
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Page 2 - Mr. Reichertz
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k)Number(if known) | K830105 K012427 | |
|---|---|---|
| Device Name | Pharmaéthyl® Local pulp and vitality testing agent | |
| Indicationsfor Use | Pharmaéthyl® Local pulp and vitality testing agent is indicated astopical pulp and tooth vitality testing agent. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
-Prescription Use (Per 21 CFR 801. 109)
Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________
Susan Runn
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Seneral Hospital Pauls ు : ్రెక్) Number
§ 872.1720 Pulp tester.
(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.