(51 days)
Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses.
Eugenone is a eugenol-free temporary cement.
This document is a 510(k) premarket notification decision letter from the FDA for a dental cement named "Eugenone." It's not a study report, and therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies for a device.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined that this 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..."
This indicates that the device was cleared based on substantial equivalence to existing predicate devices, rather than through a new clinical performance study that would generate the kind of data you're asking for.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance criteria and reported device performance: This document does not specify formal acceptance criteria for a new study, nor does it report on the device's performance against such criteria. The clearance is based on equivalence.
- Sample size, data provenance: No new study data is provided, so these details are not available.
- Number of experts, qualifications, adjudication method, ground truth type: These are all details related to a clinical study establishing ground truth, which is not present in this regulatory clearance document.
- MRMC comparative effectiveness study: This is not mentioned as part of the review for substantial equivalence.
- Standalone performance: Not applicable as no new performance study is detailed.
- Training set sample size and ground truth establishment: Not applicable as this is not a study report with distinct training and test sets.
In summary, the provided document is a regulatory clearance letter, not a technical report detailing a performance study.
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Public Health Service
SEP - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Jan A Orlowski President Scientific Pharmaceuticals, Incorporated 3221 Producer Way Pomona, California 91768-3916
Re: K051952
Trade/Device Name: Eugenone Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: II Product Code: EMA Dated: July 11, 2005 Received: July 18, 2005
Dear Dr. Orlowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares is see is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in are sectorial the enactment date of the Medical Device interstate conninetee prior to thay 20, 1978, 1978, 1978, 1978, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 19 Ameliuments, or to devreed that is is a ct (Act) that do not require approval of a premarket the rederal Pood, Drug, and Cosments , therefore, market the device, subject to the general approval appreadon (1 Mirr). Four general controls provisions of the Act include Controls provisions of the Field - The Jisting 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 If your device is classified (000 as a very and controls. Existing major regulations affecting (FMA), it may of subject to back adam adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
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Page 2 - Dr. Orlowski
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisor that 1 DTC 5 lobalites of that your device complies with other requirements Incall that I DAT mas made a actes and regulations administered by other Federal agencies. of the Act of any I ederal statutes and reguirements, including, but not limited to: registration You must comply with an the Here require (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceming (21 CFR Part 820), and if requirents as set forth in the quality bjochs (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) This letter will anow you to begin mainer of substantial equivalence of your device to a premarket notification. THE FDA mining of storestion 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), If you desire specific advice for your do 100 at 12-01-27 15. Also, please note the regulation prease contact the Other of Ochiphan virus (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outant other general miremational and Consumer Assistance at its toll-free Division of 01 01 01 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Snette y. Michael D. M.D.
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
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Appendix 5
Indications for Use
| 510(k) Number (if known): | K051952 |
|---|---|
| Device Name: | Eugenone |
| Indications for Use: | Eugenone is a eugenol-free temporary cement used in the placement of temporary or temporary placement of permanent prostheses. |
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Pair 21 CFX 801 Baspares /
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEBASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoy
(Division Sign-Off) (Division Sıgn-Off)
Division of Anesthesiology, General Hospital,
Chevices Control Dental Devices Division of Anestheslology, Doles 1021959
Page 13 of 13
Page _ 1_ of _ 1
510(k) Number: --
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.